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IN THIS ISSUE: REGULATORY ROUND UP
Special features Companion digitaltherapeutics – Finally aStep ‘Beyond the Pill’?
MHRA: Behind the scenesof Submissions
PGCPM Courseinformation 2018 inside
JOURNAL OF THE BRITISHASSOCIATION OFPHARMACEUTICALPHYSICIANS
PHARMACEUTICAL PHYSICIAN
SEPTEMBER 2017 VOLUME 27 | NO
4
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PHARMACEUTICAL PHYSICIAN
Published 6 times per annum by BrAPPRoyal Station Court, Station RoadTwyford, Reading, Berkshire RG10 9NF. Telephone +44 (0)118 934 1943 Fax +44 (0)118 932 0981 Email [email protected] www.brapp.org
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© BrAPP ISSN 0960-6548
EDITOR: DR MADHU DAVIES
EDITORIAL BOARD: DR JANE BARRETT
DR HUGH BOARDMAN
DR DAVID FOWLER
LIZ LANGLEY [email protected]
DESIGN: DANA KIDSON
EDITORIAL 3
REGULATORY ROUND UP 4Anne Hetherington
SPECIAL FEATURE 6Companion digital
therapies – Finally a step
“beyond the pill”?
Dr Matt Goodman
MHRA 12Behind the scenes –
Submissions
Rachel Hyde
DEVELOPMENT 14What makes a good
manager?
Dr Michael Atkins
REVIEW 18Grayson Perry: The most
popular art exhibition ever!
Julia Davies
COFFEE 21Katie gets political
Katie L Chain MS
NEWS 22Single form replaces separate
ethics and R&D application
MHRA and making a success
of Brexit
Macro evaluation of Oxford
Biomedical Research Centre
PEOPLE 26
PGCPM 2018 ENTRY 27
Contents
SEPTEMBER 2017 VOLUME 27 | NO
4
WHAT? The Patient Centred Outcomes (PCO) team at pH Associates are experienced in measuring treatment
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September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN
3
PUTTING THE SEPTEMBER issue ofPharmaceutical Physician to bed remindsus that the meteorological summer is atend. Where was it in the first place, youmay ask? Perhaps the answer lies in twoglorious weeks in June. It is hard,whichever way your politics lie, not tofeel a rather chill wind blowing throughthe UK.
The authors in this issue seem to feel ittoo. Pharmaceutical physicians are used tolong development timelines but, with theexception of the unforeseen incidents, theend result is usually planned for withcontingencies built in and mosteventualities considered. It is to be hopedthat this degree of planning has gone andis going on behind closed doors on theworld stage. It is hard to tell.
Political dogma aside, the development ofnew medicines must continue apace justas commerce and trade will have to.Looking through the Anne Hetherington’sRegulatory Roundup and noting theEMA’s briefing document on The UK’swithdrawal from the EU and the Newsitem from the MHRA is it good to seethat the regulators are drawing upbusiness plans to ensure that theassessment of medicines is not disruptedand that patients throughout Europe willcontinue to have access to high quality,safe and effective medicines regardless ofwhere the EMA resides. Updates on thisplanning can be found at the EMA’sdedicated website page(http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7)
The newly formed Brexit Health Alliancewhich is comprised of Academy ofMedical Royal Colleges, Association ofMedical Research Charities, Association ofBritish Healthcare Industries, Associationof British Pharmaceutical Industries,Association of UK University Hospitals,Bio Industry Association, Faculty ofPublic Health, Medical Schools Council,National Voices, NHS Confederation(including Mental Health Network, NHSClinical Commissioners, NHS Employers,
NHS Partners Network), NHS Providers,Northern Ireland Confederation,Richmond Group of Charities, ScottishNHS Chief Executive Group, Welsh NHSConfederation has produced both adocument of “asks” and an infographic inAugust 2017 outlining the key questionswhich need resolution in our sector(http://www.nhsconfed.org/~/media/Confederation/Files/Brexit%20Health%20Alliance/Brexit%20health%20alliance%20infographic.pdf)
Business as usual is very much themantra for us all just now and Dr MattGoodman offers his views on theimportant and complementary role ofdigital intervention/interaction to enhancepatient outcomes and well-being. And intimes of change the necessity of goodmanagement is revisited by Dr MichaelAtkins – we surely all have or have had a“Brett” in our lives.
You’ve still got time to get the GraysonPerry exhibition in the Serpentine Gallerybut beware it finishes on 10th September.Thank you to Julia Davies for walkingand talking us through it. And as the nexttranche of candidates for the Diploma inPharmaceutical Medicine exam get readyto sit Part 1 in mid- September we wishthem all well. The new generation arethe future of the industry.
Talking of new things, the BrAPPSecretariat welcomes a new member inearly September. Sarah Perchard joins theteam and will be on email and on thephone to you sometime soon. Sarahworked with us when she was atuniversity – in fact she built the securemembership database we still use andnow having found her love of seniorschool science teaching eroded byendless changes to the curriculum andoverarching and unfathomableadministrative demands we are delightedthat her talents are to return to BrAPP.
Dr Madhu Davies
EDITORIAL
Dr Madhu Davies
REGULATORY ROUND UP
By Anne Hetherington, Senior Regulatory Consultant, Envigo Ltd.
HERE IS THE LATEST ROUND UP OF REGULATORY NEWS FROM THE LEADING
AGENCIES, INCLUDING THE EUROPEAN MEDICINES AGENCY (EMA), THE MEDICINES
AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) AND THE FOOD AND
DRUGS ADMINISTRATION (FDA). EMPHASIS IS PLACED ON THOSE NEW
REGULATIONS WHICH IMPACT ON CLINICAL AREAS.
PLEASE CLICK ON THE LINKS BELOW TO TAKE YOU TO THE RELEVANT ITEM.
WE HOPE THAT YOU WILL FIND THIS DIGEST OF INTEREST. IF YOU HAVE ANY
COMMENTS OR QUERIES PLEASE CONTACT US AT [email protected]. ANNE
HETHERINGTON, SENIOR REGULATORY CONSULTANT
September 2017
volume 27 | No 4
4PHARMACEUTICAL PHYSICIAN
EUROPEAN MEDICINES AGENCY (EMA)
News and press releases• Medicine evaluation figures
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/document_listing/document_listing_000256.jsp&mid=WC0b01ac0580099fbb
• Conditional marketing authorisationsgive patients access to importantnew medicines earlierhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002680.jsp&mid=WC0b01ac058004d5c1
• First hormone replacement therapyfor parathyroid disorderhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/02/news_detail_002700.jsp&mid=WC0b01ac058004d5c1
• Multiplicity issues in clinical trialshttp://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001220.jsp&mid=WC0b01ac05807d91a4
Updates• Post-orphan medicinal product
designation procedures: guidancefor sponsorshttp://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196994.pdf
EUROPEAN MEDICINES AGENCY (EMA)
News and press releases• Overview of comments received
by EMA on the draft Addendum ofthe ‘ICH E11(R1) guideline onclinical investigation of medicinalproducts in the paediatricpopulation’(EMA/CPMP/ICH/2711/1999)http://www.ema.europa.eu/docs/en_GB/document_library/Overview_of_comments/2017/04/WC500226443.pdf
• First medicine for spinal muscularatrophyhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/04/news_detail_002735.jsp&mid=WC0b01ac058004d5c1
Anne Hetherington
ENVIGO.COM
• Optimising safety information formedicines in Europe throughoutproduct lifecyclehttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/04/news_detail_002723.jsp&mid=WC0b01ac058004d5c1
• Collaboration with academia to bereinforcedhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002722.jsp&mid=WC0b01ac058004d5c1
• New action plan to support SMEsas drivers of pharmaceuticalinnovationhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/news_detail_002758.jsp&mid=WC0b01ac058004d5c1
• Regulatory guidance for industry toprepare for the UK’s withdrawalfrom the EUhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/news_detail_002757.jsp&mid=WC0b01ac058004d5c1
• Green light given for newEudraVigilance system forcollection and monitoring ofsuspected adverse reactionshttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/news_detail_002752.jsp&mid=WC0b01ac058004d5c1
• Involving patients in discussions onbenefits and risks of medicineshttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/news_detail_002742.jsp&mid=WC0b01ac058004d5c1
• Regulators in EU, Japan and UStake steps to facilitate developmentof new antibioticshttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002763.jsp&mid=WC0b01ac058004d5c1
Updates• External guidance on the
implementation of the EuropeanMedicines Agency policy on thepublication of clinical data formedicinal products for human use(updated)http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001799.jsp&mid=WC0b01ac0580b2f6ba
• Guideline on goodpharmacovigilance practices (GVP):Module VII – Periodic safetyupdate report - Explanatory note,adoptedhttp://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/04/WC500225264.pdf
• Gaucher disease: a strategiccollaborative approach from theEuropean Medicines Agency andFood and Drug Administration,http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500230342.pdf
• Draft guideline for the notificationof serious breaches of Regulation(EU) No 536/2014 or the clinicaltrial protocol, draft.http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500228199&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
• Presentation - Facilitatingengagement with the FDA to allowshaping paediatric developmentprogrammeshttp://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2017/05/WC500227707.pdf
• Presentation - Implementation of the2016 Notice on the application ofthe orphan regulationhttp://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2017/05/WC500227705.pdf
• Presentation - Use of real worlddata in development programmeshttp://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2017/05/WC500227703.pdf
• Draft guideline on equivalencestudies for the demonstration oftherapeutic equivalence for productsthat are locally applied, locallyacting in the gastrointestinal tract asaddendum to the guideline on theclinical requirements for locallyapplied, locally acting productscontaining known constituentshttp://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500225230&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
• Concept paper on a guideline onthe evaluation of medicinal productsindicated for treatment of influenza,draft.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/05/WC500226734.pdf
• PRIME - The first 12 monthshttp://www.ema.europa.eu/docs/en_
REGULATORY ROUND UP
September 2017
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REGULATORY ROUND UP
PHARMACEUTICAL PHYSICIAN
GB/document_library/Report/2017/05/WC500228002.pdf
• Concept paper on the revision ofthe guideline on the role ofpharmacokinetics in thedevelopment of medicinal productsin the paediatric populationhttp://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500226734&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
• Regulatory and proceduralguideline: EudraVigilancestakeholder change managementplanhttp://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500226652&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
• Concept paper on revision of theguideline on clinical developmentof vaccineshttp://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/10/WC500196029.pdf
• Report: European MedicinesAgency’s interaction with patients,consumers, healthcare professionalsand their organisations - Annualreport 2016http://www.ema.europa.eu/docs/en_GB/document_library/Report/2017/06/WC500229514.pdf
• Concept paper on the need for thedevelopment of a reflection paperon regulatory requirements for thedevelopment of medicinal productsfor chronic non-infectious liverdiseases (PBC, PSC, NASH)http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500228852&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
MEDICINES AND HEALTHCARE PRODUCTS
REGULATORY AGENCY (MHRA)
• Early access to medicines schemeapplications: pending, refused,grantedhttps://www.gov.uk/government/statistics/early-access-to-medicines-scheme-applications-pending-refused-granted
FOOD AND DRUGS ADMINISTRATION
(FDA)
• Development of New TuberculosisDrug Regimens-Scientific andClinical Design Considerationshttps://www.newtbdrugs.org/news/us-fda-development-new-tuberculosis-drug-regimens-scientific-and-clinical-design-considerations
• FDA approves Keytruda(pembrolizumab), the first cancertreatment for any solid tumor with aspecific genetic featurehttps://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm
• E14 Clinical Evaluation of QT/QTcInterval Prolongation and ProarrhythmicPotential for Non-Antiarrhythmic DrugsQuestions and Answers (R3) Guidancefor Industryhttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073161.pdf
WORLD HEALTH ORGANISATION
• WHO launches global effort tohalve medication-related errors in 5yearshttp://www.who.int/mediacentre/news/releases/2017/medication-related-errors/en/
September 2017
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SPECIAL FEATURE:Companion digital therapeutics – Finally a Step ‘Beyond the Pill’?
By Dr. Matthew Goodman MB.ChB, Dip.Pharm.Med., MFPM
September 2017
volume 27 | No 4
8PHARMACEUTICAL PHYSICIAN
A RECAPLast time we met I described theemerging universe of digital health, andtried to make some sense of it. Apartfrom a general backgrounder, the intentwas to draw a distinction between theareas of digital health that may becomplementary to the development andmarketing of medicines (e.g.telemedicine) and others that areunlikely to influence, or be influencedby medicines (e.g. electronic patientrecords).
For this, the second of two articles, theidea is to hone in on one aspect of thisuniverse in particular – ‘DigitalTherapeutics’, and explore the ways inwhich these may improve patient careand how they and medicines may worktogether in the future.
You’ll remember that DigitalTherapeutics are purpose-designed
software packages to educate, coachand support patients in their quest forbetter outcomes. To be more specific, aDigital Therapeutic offers a focus onpatient engagement and userexperience and may:
• Provide comprehensive informationabout the condition in question,including online structurededucation and self-directedlearning
• Support medicines managementthrough concordance andadherence tools, (including SMSand app-based reminders andalerts) and for self-administration ofmore complex medicines
• Offer advice for self-management(including video tutorials, exerciseand healthy eating strategies andplans) and tools to enable thisMatthew Goodman
• Empower patients to capture theirown data from multiple sourcesincluding third party apps and devices
• Provide meaningful data visualisationto support appropriate target setting
• Allow shared care-planning andhealthcare system integration(including automated alerts anddashboards for healthcareprofessionals)
• Offer support for patient/carernetworks (including family, friendsand community members)
• Aggregate data and reporting (PROM,PREMS, patient feedback, systemanalytics)
By definition, these Digital Therapeuticofferings are designed to improvepatient care and even health outcomes.So as you might expect, often they areput into clinical studies, to assess theclinical benefit on patient outcomes, andin doing so they can be seen ashealthcare interventions in their ownright – not just as a support for anotherintervention.
DOUBLE IMPACT?But what if, rather than standing aloneas an intervention, Digital Therapeuticswere designed specifically to harmonisewith a specific medicine, to the pointthat the service comes bundled with themedicine at the point of prescription.This approach is rapidly becoming
known as ‘Companion DigitalTherapeutics’.
Let’s rewind a little.
The idea that software can support andimprove the experience of anotherproduct is nothing new. From thecontrol of your stereo, to the monitoringof your tooth-brushing skills, manyproducts these days come with apurpose-built app or website thatenhances the experience. Sometimesthis is as simple as offering moreinformation about the product to beaccessed online, but often thesophistication goes further – into therealms of control and monitoring of theprimary product. This type of softwarecan be thought of as a ‘secondary
feature’ of the main product: not thecore value itself, but an enhancement.The acid test is to ask what value thesedigital additions have if the product towhich they are attached is removed. Theanswer – if we are talking aboutsecondary feature software – is none. Inthe world of medicines, a website thatsupports the launch of a new medicinefalls into this bracket.
Now let’s consider digital hardware andsoftware together. An insulin pump, forexample, controlled by its own softwarethat resides within the unit itself or via asmart-phone app. This is a differentsituation – here the software is anintegral part of the overall value. Unlikethe electric toothbrush that still functions
very nicely without the app thatmonitors it, the digital hardware andsoftware in an insulin pump don’t workat all without one another, each part isentirely reliant on the other for itsfunctionality. In this case both thesoftware and hardware are considered aMedical Device.
Finally consider a third example – andfor this we need to step away fromdigital altogether. This third example isof two interventions that work wellalone, but even better together. For thislet’s consider anti-hypertensivemedicines. Take a diuretic – lower yourblood pressure, take an ACE inhibitor –lower your blood pressure, take both –get the blood-pressure lowering benefitsof both. You can argue about whetherthe effects are additive or synergistic,but either way the benefits of usingboth together are clear.
Now…deep breath…consider replacingone of those medicines with anevidence-based digital therapeutic – asoftware package designed to helplower blood pressure through the use ofeducation, information, tracking andgoal setting. Something that has alreadybeen proven to lower blood pressure
SPECIAL FEATURE:Companion digital therapeutics –
Finally a Step ‘Beyond the Pill’?
September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN
Continues on page 10 ��
NOW… CONSIDER REPLACING ONE OF THOSE MEDICINES WITH AN
EVIDENCE-BASED DIGITAL THERAPEUTIC….
9
SPECIAL FEATURE:Companion digital therapeutics –
Finally a Step ‘Beyond the Pill’?
PHARMACEUTICAL PHYSICIAN
alone - through its effect on behaviouralchange.
It’s easy to see how these twointerventions, having completelyseparate mechanisms of action, but bothcapable of achieving the same endpoint,could work well together. Not least,because digital interventions have suchan enviable side-effect profile comparedto medicines, and this combined withno interaction issues, mean that focusfor the patient, the clinician and theregulator can shift entirely to theenhanced efficacy.
Let’s take this a step further and look atsome of the specific case where a
Companion Digital Therapeutic may notjust support, but amplify the benefits ofthe medicine in question:
EFFICACYPlenty of digital tools havedemonstrated efficacy at improvinghealth. From patient reported reductionsin anxiety with mood managementapps, to biochemical changes in adisease pre-cursor such as bloodpressure or HbA1c, the evidence-baseis growing in multiple therapeutic areas.
Head-to-head evidence againstmedicines is lacking, though there is agrowing acceptance that digitallymediated behavioural change may lead
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to benefits at least as large in magnitudeat the medicines prescribed for the samereason.
But why compete with one another,when together these interventions mayresult in additive, or dare-I-say-it, evensynergistic benefits. Again the evidenceis sparse, but in the coming years we arelikely to see a plethora of well-designedclinical studies emerging that maydemonstrate this. Some will use specificmedicines with generic (though stilleffective) digital tools, though I suspectthat the greatest benefits will be seenwith digital tools specifically designed tosupport the medicine in question.
This will be a fertile ground for Phase 4studies.
SAFETY AND TOLERABILITYLet’s say your new medicine is knownto have an early tolerability issue, onethat can result in low compliance rates,or even worse - a patient giving up onthe medicine altogether.
What if the Companion DigitalTherapeutic was able to coach themthrough this period of the treatment,offering practical tips on themanagement of the side-effect, alongwith reassurance that the issue wouldresolve?
This line of thought can be continued toa variety of tolerability issues, allowing abalanced and personalised supportservice to patients that avoids the worryof reading the PIL side-effect list, orworse Googling the symptoms.
This could have benefits outside ofcompliance, and patient support. Thegathering of large-scale post marketingsafety data could come directly frompatients, with secure patient portalsallowing the reporting of tolerabilityissues and safety events without havingto go via a clinician.
Perhaps this approach could evensupport post-marketing commitments,and Risk Management Plans.
ADMINISTRATIONSo your medicine isn’t once-a-day oral,but requires a less convenient dosingstrategy, injection? Is this left to thepatient to learn how to do this? And ifso what support are they offered inunderstanding how to take themedicine? Are you offering practicaladvice, including videos and tutorials?
A Companion Digital Therapeutic canoffer this, in the context of apersonalised understanding of thepatient and their needs. Are they old oryoung? Have they had the conditionbefore? Do they have other issues thatmay make dosing a challenge?Delivering the right content, at the righttime, to the right patient.
GLOBAL SCALABILITY, LOCALCOMPLIANCEIn an increasingly regulated andoutcomes driven healthcareenvironment, the development ofeffective and successful DigitalTherapeutics must take account ofgeographical variations in regulatoryrequirements, data protection legislation,prescribing practices, healthcare systemconfigurations and outcome and cost-saving expectations.
The lower costs of development andhuge scalability allow CompanionDigital Therapeutics to be developed foruse in a single territory, and then easilyand cost-effectively reconfigured forother global markets.
SUMMARYIt seems obvious that empoweringpatients to make appropriate self-management choices by increasing theircondition knowledge and supportingpositive behaviours can improveoutcomes in long-term conditions. Thebenefits of this don’t stop with theintervention itself, but may have a halo-effect on medicines that the patient istaking.
If we extrapolate this assumption, andthink of these benefits as not a halo-effect, but something that can be
designed for, and measured – then weenter into the field of Companion DigitalTherapeutics.
Medicines, particularly medicines forlong-term conditions, aren’t perfect.Digital health alone isn’t either. Buttogether at the point of prescription, liessomething that is better than eitheralone.
SPECIAL FEATURE:Companion digital therapeutics –
Finally a Step ‘Beyond the Pill’?
September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN 11
MHRA:Behind the scenes of: Submissions
By Rachel Hyde, 3 July 2017
September 2017
volume 27 | No 4
12PHARMACEUTICAL PHYSICIAN
THE INFORMATION PROCESSING Unit(IPU) is a part of the InformationManagement Division at MHRA. As themain submission hub for the Agency, inIPU we are responsible for making sureregulatory applications relating toMarketing Authorisations and ClinicalTrial Authorisations for medicinesproducts are entered and validated ontoour ‘Sentinel’ database system.
This work is managed by various teamswithin IPU consisting of key functions,technical and content validation ofsubmissions and Licence Management.We work in a very fast pacedenvironment with around 100,000submissions a year and an intense dailyallocation process to effectively managethe processing of more than 400applications we receive each day!
Our Information Processing team have
an important role in using theirspecialist knowledge to interpret andvalidate regulatory applications receivedfrom industry. In some areas, we willfinalise the application, in others wewill prepare a high-quality case folderfor subsequent assessment by ourLicencing or Vigilance and RiskManagement of Medicines Divisions.
The team work hard to make sure eachapplication submitted is technicallyvalidated and that best practicestandards are adhered to. This can be avery manual and labour intensiveprocess which involves identifying andcategorising these work types eachmorning.
The process begins when data isdownloaded from both the MHRA Portaland the Common European SubmissionPortal (CESP) where it is then
categorised and allocated to theappropriate teams for technical andbusiness validation. We face variedchallenges and these can includesituations such as distinguishing thedifference between a new submissionand a response to Requests forInformation (RFI). For example, withCESP submissions we are reliant on theapplicant to categorise the submissionwith the correct Regulatory Activity andSub activity. To ensure smoothprocessing of an application weencourage applicants to avoid the use ofSub Activity ‘Not applicable’ as this mayresult in delays and incorrect processingof an application. It is also importantthat the MHRA reference number isquoted on the submission of the RFIe.g. PL XXXXX/XXXX – XXXX. Withoutthis number, it is difficult to associatethe RFI which can result in a delay toassessment.
During the validation process theapplication is validated againstregulatory requirements, and theAgency’s ‘Sentinel’ Database is updatedaccordingly. Failure to provide thecorrect documentation may lead toinvalidation of a submission. The unit isconstantly looking at better ways ofworking to reduce any delays forassessment. One recent improvement isour ‘Pay on Invoice’ initiative whereapplicants are no longer required tosubmit proof of payment with theirapplication, rather are invoiced for it.This is a welcome change across theboard, reducing the regulatory burden
and making the end-to-end processsimpler, easier and quicker.
While the manual constraints,unpredictability and fluctuating volumesof submissions can bring its challenges,the team are committed to ensuring theAgency meets its legislative andregulatory obligations. We are currentlyfocusing our efforts on optimisingoperational performance and efficiencyto deliver improved value to both ourinternal and external stakeholders.
In the future we aim to harness newtechnology to allow us to continue tomeet our regulatory demands throughless manual processes, better customerservice and data quality.
Let us know below if there are anyother departments at MHRA you'd liketo see Behind the Scenes of.
Read more athttps://medregs.blog.gov.uk/2017/07/03/behind-the-scenes-of-submissions/
Copyright MHRA
MHRA:Behind the scenes of:
Submissions
September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN
…FOCUSING…EFFORTS ON OPTIMISING OPERATIONAL PERFORMANCE
AND EFFICIENCY TO DELIVER IMPROVED VALUE….
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DEVELOPMENT:
What makes a “good manager”?
By Dr Michael J Atkins BSc (Hons), MB BS, FFPM
September 2017
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14PHARMACEUTICAL PHYSICIAN
A VERY CLOSE friend of mine is being“managed” by a foul mouthed bullywho can turn his charms on when infront of his seniors. Let’s call him “Brett”(not his real name). “Bad” managers do,I am afraid, exist.
In my 34 years as a pharmaceuticalphysician I have line managed bothlarge and small teams of people and Ihave made mistakes. For me, a “goodmanager” is a person who gets the bestout the people they manage to themutual benefit of the company andthose managed. It’s a simple as that.Well – not quite. People are not majorappliances you can switch on and off,and replace and dump the faulty ones.Even now, I can hear some of youthinking “I wish”. Tut tut.
You may have read so far and think “sowhat?” That’s good because the chancesare you are a good manager and this isall obvious stuff. Nevertheless, perhaps Ican share with you some thoughts withyou.
• “Management” vs “Leadership”? Theseare not interchangeable terms. Forme, “leadership” is getting people tofollow a vision whilst “management”is about implementing a vision. Ofcourse, ideally, leaders have somemanagement skills and managershave some leadership skills. However,great leaders can be awful managersand great managers can make awfulleaders. Good managers may ascendto managing directors but that stilldoes not make them an automaticleader. In leadership you must havecharisma; in management you mustdeliver. In leadership you inspire; inmanagement you perspire
Brett sees himself just as a great leaderand thinks that is “management”. That isnot a good start for a manager.
• Is it for you? – It is very common tobe expected to take on more andmore line management responsibilitiesas you ascend in your career. I haveseen great individuals fall apart whenpromoted to a people managementrole. There are “natural” managers outthere but for others it is wise toask/be sent on a formal managementtraining course as early in your linemanagement role as you can. Ifnothing else, read some bookson/Google management theory. Whenyou experience a great manager (or,indeed a poor one), reflect what it isand what they do that makes themwhat they are.
Brett has excellent technical knowledgeabout the therapy area and the productsbut has never had any formal orinformal management training. Indeed,he was recruited by and reports tosomeone who has never had any formalor informal management training.
• So, what is your management style? – Be genuine - Try to match it with yourown personality. Telling people to dosomething (autocratic style) may beneeded if the ship is sinking but is notfavoured, in my opinion, for everydaywork. Try to be democratic most oftime. Letting them get on with itwithout guidance can also be an optionbut be there to catch them if they fall.Also, try to be consistent.
True to himself, Brett’s autocratic (andonly) style fits perfectly with hispersonality. But, what is said in private
may not be the truly reflected in whatthat appears in a follow-on Email. Heprotects himself.
One size never fits all – you will findpeople like to be managed in differentways. Adapt your management style tothat which fits for mutual benefit.
Brett can switch; line reports get rule byfear whilst, with his seniors, it’s smarmby charm.
• Employment Law and you – Do notinvent what you think is correct.Employment Law exists to protect therights and dignities of all. It can becomplex. For example, what youthink is harmless teasing/banter canbe deeply offensive and get you andthe company into trouble. Do youunderstand the Law? Seek advice fromHuman Resources (HR) on generaland specific people issues before youact. Also, know and follow thecompany rules but have a sense offairness (applied equally to all) for
time off in lieu when someone hashad to work unpaid overtime to meeta company deadline, a familyemergency has arisen, etc.
Brett makes threats. His behaviour iseventually going to get him and thecompany into trouble but not before alot of unhappiness and stress for his linereports.
• So, what should I be doing as amanager?
Guide, train, counsel, and mentor – to
get the bad to get better, the good toget great, and the great to fly.
Brett does have a few tricks up hissleeve he likes to share – like, slippinginto restricted areas of a hospitaluninvited when someone opens a code-locked door. Nice role model.
Be equitable - Treat and be seen to treatall as equals. Line reports may becomeyour friends but remember, your role isa company employee as their manager.Do not friendship cloud your judgment -no favourites, please.
Equitable? No. Brett has those he treatsworse than others.
Show respect – Of all the things a“good manager” is, this is it.
Brett only respects his own abilities. Hethinks he is infallible.
Humour can help – This is not foreveryone. I am not suggesting you
should be a comedian (far from it) but aself-effacing comment can diffuse atense moment.
This is not part of Brett’s repertoire oftorture.
Take time - People are time-consumingand complex. Sadly, your company roleoften means that managing becomes aside line to your primary task of, forexample, being a medical affairs medic.This is a mistake. People managementneeds your full attention. Some will findthis multitasking role easy and
rewarding. Others will find it arduousand stressful (not made any easier bythe 50 page tome of company appraisaldocuments to be completed quarterly oneach line report).
To be fair, Brett does take time withmost of his reports. Quality agony. Theyfear him.
Realise that you cannot please
everyone – It is always nice to be likedbut there will be times when things mayneed to be done that does not put youin favour with an individual or the team.Similarly, familiarity can breed contempt.Always maintain a professional positionand be prepared to explain you actions.I do not like the Tax Man but Iunderstand what he needs and so I do itand respect him.
Brett is under the illusion that respectcomes with the job. As such, he feels hehas a Green Card to do as he wishes.Making people happy is not on theagenda, anyway.
Keep confidences – People may sharepersonal matters. Do not pass these onto HR without their permission unlessthere is an Employment Law
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ONE SIZE NEVER FITS ALL - ADAPT YOUR MANAGEMENT STYLE…FOR MUTUAL BENEFIT
15
DEVELOPMENT:
What makes a “good Manager”?
PHARMACEUTICAL PHYSICIAN
requirement to do so.
Alarmingly, Brett has been indiscreetabout his team with his peers.
Deliver tasks without dead bodies –
When a critical task is required withtight deadlines, it is easy to see the taskas the focus and forget the people. Bigmistake. The good manager can, onoccasion, ask more of his/her peoplethan normal and they will deliver. But,do not take that as the norm. Do notdrive them with your foot to the floorall the time. You will crash the bus.
For Brett, the task is everything. Peopleare just a means to an end. He wins,you lose is OK.
Recruit the right people – As amanager, you should be involved inreplacing those in your team who haveleft and adding to your team asbusiness needs arise. Recruitment is askill that has multiple facets and mayinvolve personality tests, IQ tests,interviews, presentations, groupinteraction… I could go on. Beobjective but at the end of the day, youwill be managing them.
As, inevitably, people leave his team, herecruits replacements – younginexperienced people who will notchallenge him or complain.
Hold 1 to 1 meetings – These are two-way times. You talk, they listen andthey talk and you listen. Time to praiseand constructively criticise, withsuggestions to improve. That means youtoo!
Brett shouts and swears at his linereports when he thinks his ideas arechallenged. There are no witnesses.
Have team meetings – Make themregular, relevant and give enough time(neither too long to too short). Rotatethe chairperson and the minute-taker togive each the experience. Rotate thelocation for field-based staff. Big issuesmay need a separate meeting.
Be reasonable about travel. Having ameeting that ends at 5pm on a Friday isinconsiderate on those with a 3 hourdrive home. People do have a lifeoutside of their work. I read thatsomewhere.
Don’t get into personal performanceissues in team meetings unless it’s toshow recognition for a particular jobwell done.
True to form, Brett has long meetingsthat start and finish at times that suitonly him, ignoring the practicalities ofthose with young children to look after.He does not like his ideas being openlychallenged and shows it. Some havenoticed steam coming out of his ears.
Have fun – “All work and no playmakes Jack a dull boy.” A goodmanager should build in some time forpeople to relax and have someenjoyment. A simple meal out cansuffice after a team meeting but youcannot insist people attend the meal. Becareful, though. I was once asked toattend a team building event thatinvolved swimming. Some of the teamfelt very uneasy exposing their bodiesto others. One lady had a huge scar.Another event I recall failed badly whenone participant crashed into a fence andsustained facial injuries.
You WILL come to the Pig’s Trotter Innfor a team meal or else!
Do Appraisals – I was once forced (!) todowngrade a couple of my line reports(and their bonuses!!) to fit the bellshaped curve required of each team’sabilities. “You cannot have so many Agrade people”, I was told. Not good butcompany rules. I came clean with thoseindividuals. I left that company soonafter. People must be rewarded fairly.Appraisals should not raise surprises. Ifthere is an issue, tackle it right away –do not wait several months to dump iton an unexpecting line report.
Do not shy away poor performance. Todo so reflects badly on others in the
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team who see a colleague “getting awaywith it”. In a 1 to 1, establish and agreewhat is expected and what they are, infact, under delivering. Be polite and findout why the gap. Do they need training?Is the task too big for them in scale ordeadlines? Mutually agree a plan andfollow up.
Most people want to be successful butthere are occasions that may need aformal HR involvement. Alwaysdocument what has been said and doneand share that with your line reportFOR THE RECORD! If there aregrievances, your written notes at thetime will be invaluable. Retrospectivenotes can appear suspicious.
New to the job, Brett’s formal appraisalsare yet to be undertaken. I would havea few pints of blood on tap.
Give rewards and bonuses - Catchpeople do things well - carrots arebetter than sticks. Show recognition. Becareful with league tables andpercentage growth. Do they show thetrue picture? Is rewarding a 100%improvement fair (when someone hasonly moved from 1 to 2) when ignoringsomeone else has only improved 10%(but moved from 100 to 110)?
Brett likes success. That makes him lookgood. For the top people in his team,there are company (not Brett) instigatedrewards.
Describe (not act out) your negative
emotions – You are human. Whenthings go wrong, you can say what you
feel but do not show it. Stay in control.“That piece of work was awful, I amsorry to say. I feel very upset aboutthat” is OK. Shouting in anger “You areawful for doing that work so badly” “ isnot OK. The former criticises the taskand leaves room to work onimprovements whilst retaining respect.The latter is a personal attack. Critiquehow the task was done not to theperson who did it. Look uponproblems as if they are “on the table infront of you”, not inside the person.Then, you can then both look at thetask objectively.
If you still feel like shouting, take it outon a squash ball. Have a mentoryourself for those times you feel youcould get more done with a kind wordand a gun than just a kind word– butchose your mentor carefully.
We end here, with Brett using thefoulest language to beat and belittle histeam in 1-to-1s. He has the emotionalcontrol of a hand grenade with the pinpulled out. Shouting at your footballteam to score more goals will not scoremore goals. What is perhaps the saddestthing is that “Bretts” really exist. Takecare.
DEVELOPMENT:
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September 2017
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CRITIQUE HOW THE TASK WAS DONE NOT THE PERSON
WHO DID IT
REVIEWS
September 2017
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18PHARMACEUTICAL PHYSICIAN
“GRAYSON PERRY: THE MOSTPOPULAR ART EXHIBITIONEVER!”The Serpentine Gallery, Hyde Park,
London
Running till 10th September- you justhave time to get therehttp://www.serpentinegalleries.org/exhibitions-events/grayson-perry-most-popular-art-exhibition-everA TITLE LIKE that makes a bold claim,and boldness is something we havecome to expect from Turner Prize-winning artist Grayson Perry.
Housed in idyllic Hyde Park, theSerpentine Gallery’s location should notlull this exhibition’s visitors into a falsesense of contentment with the worldaround them. Outside may be abeautiful and quintessentially British,Grade II listed gallery, once a teapavilion, but inside Perry lays bare thereality of what Britain has come to be.
The exhibition is typical Perry in thatmyriad mediums, such as sculpture, andtapestry are explored, not to mentionthe works in ceramic, which take centrestage. We see, too, the motif of AlanMeasles, Perry’s beloved teddy bear,rendered in ceramic and pebbles.Ordinary things have a touch ofGrayson Perry added to them and theend result is, as ever, one which ismildly unsettling, like feeling somethingon your neck that could be either yournecklace or a cockroach. There is alsomuch reference made to Perry’s alter-ego, Claire, including a photograph ofPerry as Claire next to his wife, whowears an outfit akin to traditionalRussian peasant dress, whilst visiting ashrine Perry made in honour of theirmarriage.
However this exhibition, like the artisthimself, manages not to be a case of sofar, so inevitable; it is not Perry merely
Grayson Perry, Installation view, Serpentine Gallery, London
(08 June 2017 – 10 September 2017). Image © 2017 Robert Glowacki
reworking tired, tried and trustedformulae. There is a new energy to thiswork, and it can only be described asone of anger. A turbulent roilingpervades the galleries as you walkthrough, one reminiscent perhaps of theearly works of David Hockney, whoalso thought counter to society.
This anger is what characterises theexhibition and makes it so profoundlydisquieting. As a student in a liberaltown I can console myself that I’mperhaps overly sensitive to the societalchanges we are experiencing in the
wake of the watershed that was Brexit.Am I imagining that society seems moreracist, fascist, hostile? Well, althoughPerry has been called ‘one of the mostastute commentators on contemporarysociety and culture’, he is, at the mostcrude analytical level, a fundamentallyestablishment old white man. So if he,too, feels what my peers and I feel, thenit is real. And that, like Perry’s work ingeneral, is unsettling.
The exhibition doors open onto aceramic double-headed pig, with severallabelled coin slots on its back, the idea
being that you can choose the label thatbest describes you (‘rich’, ‘young’, etc)and put your donation into it, butthough the money is given throughwhat differentiates us, the coins all go tothe same place. This idea of unitythrough differentiation becomes a motifthroughout the exhibition, culminatingin the much-publicised ‘Brexit vases’called Matching Pair. Perry asked usersof social media to describe Britain, andfor their thoughts on Brexit, and made aLeave and a Remain vase accordingly.They are quite similar, with differencesbeing as small as Remain featuring aWaitrose logo in place of Leave’sCadbury logo. Perry states ‘we all havemuch more in common than that whichseparates us’, and in the context ofthese vases this certainly seems so. Yetsimply stepping away from the cabinetshousing the vases, which face eachother, is enough to dispel any thoughtsof faith in humanity. The room in whichthe vases ‘talk’ to one another also playshost to two colossal tapestries, whichflank opposite walls, and speak of thedecaying which Britain as a society isexperiencing. This social commentaryextends to the West at large, withpebbles composing figures similar totraditional tribal statues, that showindigenous people being suffocated by
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Continues on page 20 ��
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Grayson Perry, Puff Piece, 2016, Glazed ceramic, Courtesy the artist and Victoria
Miro, London Photography: Stephen White © Grayson Perry
REVIEWS
PHARMACEUTICAL PHYSICIAN
the demands of capitalism; they buckleunder the weight of the West whichthey carry.
Not every piece is a soul-searing realitycheck, however, with a skateboardfeaturing a mock- medieval image ofthe Duchess of Cambridge dubbedKateboard for seemingly no apparentreason other than the pun factor. Alarge metal skull, Head of a FallenGiant, is very poignant but not for anyone more topical reason than another.
Overall, the exhibition speaks volumeson how society has changed since23.06.2016, but not all the pieces werenew for this exhibition, which is aneedling reminder that the attitudeselucidated by Brexit have been aroundfor some time. This, and their beingunapologetically displayed, was quitedistressing. I could not stay for long.
3/5 stars
By Julia Davies
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Grayson Perry, King of Nowhere, 2015, Cast iron and mixed media,
Photography: Stephen White © Grayson Perry
September 2017
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COFFEE BREAK: Katie gets political
by Katie L. Chain MS ( a nom de plume)
KATIE L CHAIN MS TAKES A CYNICAL
VIEW OF THE POLITICAL AND
POLITICAL SCENES. HOLD ON TO YOUR
HATS.
21
EVER HAD A “bad hair” day? Whatabout a “mad scare” year? Now is thetime to redefine some of those well-trodden words we hear every day.Oxford English Dictionary – take note:
REFERENDA – a series of painful publicvotes on the same topic and undertakenuntil you get the result you want.
WRECKXIT – to destroy or severelydamage (a structure, vehicle, or similar).Synonymous with “WRECK”.
EU – (short for “Extremely Useless). Aterm of despair.
AM-DRAM – (short version of “AmateurDramatics”). The behaviour of minorpoliticians.
TWISTER – (a) a mid-1960’s party gamefor adults and children (b) a 21stcentury party game for major politicians.
LEFT WING/RIGHT WING – two sides ofan aircraft to keep it up in the air.
FAKE NEWS – the publication of apolitical party’s manifesto.
RICH – voters who have more moneythan those they vote for.
FIRST PAST THE POST – A voting systemthat favours the winner.
FLOATING VOTER – someone who votestactically and gets the wrong personelected by mistake.
TRUMPED – when you think you have awinning hand and the real winnerchanges the rules to fix you.
PERSONAL HEALTHCARE – what youdelegate to healthcare professionals soyou can focus on more importantthings.
NHS – a bottomless trench into whichmoney is poured.
BMA – a strikingly importantorganisation.
PHARMACEUTICAL INDUSTRY– makers ofinnovative drugs that are perceived tobe too expensive until you need them.
NICE – (short for “Not Initially CostEffective). An august body open to dataand pressure.
MUTUAL RECOGNITION – a redundantterm soon to be replaced by “GO-IT-ALONE”.
DIESEL – a fuel of black connotationswhich, if you are green, that makes yousee red.
I bet that got you thinking!
NEWS:
Single form replaces separate ethics and R&D applicationforms on a UK- wide basis
From: Human Research Authority
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22PHARMACEUTICAL PHYSICIAN
FROM THE EVENING of 28 June 2017 acombined IRAS form that merges theREC and R&D forms has been usedacross the UK. Already in place forprojects where the lead NHS R&D officeis based in England, the single IRASform should be used for projects wherethe lead NHS/HSC R&D office is basedin Northern Ireland, Scotland or Wales.
The streamlined single system is a resultof the work of the Four NationsNHS/HSC Compatibility Programme andcontributes to making it easier forapplicants to undertake research in theNHS/HSC. Adoption of the single IRASform UK-wide will save time and effortfor applicants and sponsors and helpbuild UK-wide consistency.
For projects led from Northern Ireland,Scotland, or Wales, although a singleform will replace the separate REC andR&D forms, this single IRAS form willcontinue to be separately submitted forethical review (where applicable) andreview against NHS/HSC standards asper current processes. The singleelectronic submission of the IRAS formand accompanying documents for bothethical review and for review againstNHS/HSC standards will remain in place
for projects led from England.
Over the coming year more work willbe carried out to further streamline theapplication process, so that the currentsubmission functionality for projects ledfrom England is extended to projectsled from Northern Ireland, Scotland andWales.
Applications for Research Tissue Banks,Research Databases and for researchprojects not taking place in theNHS/HSC will continue to use the RECForm. Applications for studies wherethe lead NHS R&D office is based inEngland are not affected by this change.
Applicants are encouraged to read theadvice and guidance within IRAS and toseek support from their lead NHS/HSCR&D office.
September 2017
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NEWS
23
MHRA AND MAKING A SUCCESSOF BREXITPublished: 27 June 2016
Last updated: 17 July 2017
The Agency's response to the outcomeof the EU referendum.
FOLLOWING THE OUTCOME of the EUreferendum, the Medicines andHealthcare products Regulatory Agency(MHRA) is working closely with theGovernment to analyse the best optionsand opportunities available for the safeand effective regulation of medicinesand medical devices in the UK.
While negotiations continue, the UKremains a full and active member of theEU, with all the rights and obligations ofEU membership firmly in place.Working with our partners, stakeholdersand customers, our focus remains:protecting health and improving lives.
MEDICINES REGULATIONPlaying a full, active role in Europeanregulatory procedures for medicinesremains a priority. We contributesignificantly in both the centralised anddecentralised regulatory procedures,including new rapporteur and referencemember state (RMS) appointments, andmaintain our programmes forimplementing EU legislation as requiredby our obligations as a Member State.We are also fully engaged in European
and national scientific advice servicesand in delivering our EU inspection-related duties.
DEVICES REGULATIONOur role in regulating medical devicesand in vitro diagnostic (IVD) devicesremains integral. We oversee theessential work of the five UK NotifiedBodies; together they are responsiblefor assessing the majority of devicescurrently placed on the EU market. Ourpreparations to implement proposednew Regulations for Medical Devicesand IVDs continue.
VIGILANCE AND MARKETSURVEILLANCEWe maintain our role in vigilance,market surveillance and taking directaction, where needed, to protectpatients and public health, and wecontinue to co-ordinate with otherCompetent Authorities, across Europeand internationally, in these and otherareas.
MHRA will be engaging widely with ourstakeholders to fully understand andmaximise the opportunities of Brexit.
FUTURE REGULATORYPARTNERSHIPOn 4 July the UK Government gave aclear, public statement of its desire toretain a close working partnership inrespect of medicines regulation afterthe UK leaves the EU, in the interestsof public health and safety. Thestatement, published in the FinancialTimes, by the Secretary of State forHealth and Secretary of State forBusiness, Energy and Industrial Strategylaid out the three principles which willunderpin the development of a post-
NEWS:
PHARMACEUTICAL PHYSICIAN
Brexit regulatory system for medicinesand devices: patients should not bedisadvantaged; innovators should beable to access the UK market as quicklyand simply as possible; and we willcontinue to play a leading role in bothEurope and the world in promotingpublic health.
EMA/EU & CMDh notices to MarketingAuthorisation Holders
We are aware of the recent notices toMarketing Authorisation Holders issuedby the EMA/EU-27 and CMDh advisingof preparations MA holders may want toconsider ahead of the UK’s exit fromthe EU.
Until the exit negotiations areconcluded, the UK remains a fullmember of the EU and all the rights andobligations of EU membership remain inforce. We therefore continue to play afull role in the network and toundertake our work as a ReferenceMember State (RMS) in the decentralisedprocedure, and as (co-) rapporteur inthe centralised procedure. If, howeveryou do want to consider preparation forany potential changes to marketingauthorisation or RMS, please see theinformation provided by the EMA andthe HMA.
Whatever the outcome of thenegotiation we will continue tocollaborate with all involved to deliverthe current speed of authorisations,access to new and innovative medicinesand devices and to continue to ensurethe quality, safety and efficacy of allmedicines and devices, to safeguard anuninterrupted level of public healthprotection.
Statements are also available from theBritish Pharmacopoeia and the NationalInstitute for Biological Standards andControls (NIBSC)
■
NEW PUBLICATION: ‘MACRO’EVALUATION OF THE NIHROXFORD BIOMEDICAL RESEARCHCENTREThe Oxford Biomedical Research Centre(BRC) was established in April 2007with funding from the National Institutefor Health Research (NIHR). OHE andRAND Europe were commissioned bythe Oxford BRC to undertake aprogramme of top-down evaluations ofaspects of the impact of the BRC sinceits inception.
This programme of research has lookedat the health, economic and scientificimpact of Oxford BRC’s researchactivity, whether achieved directly fromthe outcomes of the many specificpieces of BRC-supported research, orindirectly due to the BRC’s impact onresearch activity/awareness/culture inhealth services and industry.
The evaluation, conducted from autumn2015 to mid-2016, consisted of threeseparate but related studies:
The impact of Oxford BRC onhealthcare provision by OxfordUniversity Hospitals (OUH): This wasassessed through a qualitative, interviewbased study, in which we sought toidentify local impacts of the Oxford BRCon healthcare and on OUH. We wereinterested in both the direct and indirectimpacts of Oxford BRC-related research.The results of this study have beenpublished previously.
The impact of Oxford BRC on industry:This study was based on a survey ofcompanies identified by Oxford BRCand follow-up interviews with a sampleof them to build case studies ofcommercial collaborations.
Bibliometric study: An exploratorybibliometric analysis was conducted toprovide quantitative information onchanges following the inception of theOxford BRC in research publications bythe University of Oxford and OUH, andon co-authorship collaborationsbetween those organisations, and
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between them and industry ascompared to two comparators.
Overall this programme of researchindicated that the Oxford BRC has had anumber of positive impacts on healthcare provided at OUH, through bothdirect and indirect effects. It is clear thatOxford BRC research plays a major rolewithin the totality of research activity atOUH. In particular, Oxford BRC has:
• Added positively to the reputation ofOUH, and has facilitated collaborationbetween OUH clinical staff andacademic researchers;
• Had a positive effect on commercialactivity (although note that theseresults are indicative only as theindustry study was hampered by avery low survey response rate);
• Been associated with an increase inthe number of publications andcollaborations amongst relevantinstitutions within the Oxford region.
Our work may have been too early tocapture important longer-term changes,particularly given that the creation of theBRC was an incremental change in anenvironment where there was alreadymuch academic research. Following upon each of these three studies couldprovide greater insight into the overall‘macro’ impact of the Oxford BRC.
The full report can be downloaded here:https://www.ohe.org/publications/%E2%80%98macro%E2%80%99-evaluation-nihr-oxford-biomedical-research-centre-0#overlay-context=
■
NEWS:
September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN 25
PHARMACEUTICAL PHYSICIAN CONTACT: Liz Langley
[email protected] 0118 934 1943
Advertise here or on the BrAPP website.
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PEOPLE
September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN
Professor Sir Michael Rawlins re-
appointed Chair
Professor Sir Michael will return as Chairfor a second term.
In August 2017, the Medicines andHealthcare products Regulatory Agencyannounced the re-appointment ofProfessor Sir Michael Rawlins as itsChair yesterday for a further 3 years.
Since taking up the position of chair atthe Agency in 2014, Sir Michael hasoverseen the Agency’s work as aneffective regulator of medicines andmedical devices across the UK. He haspromoted the first-class science andresearch carried out in each of theAgency’s centres; the National Institutefor Biological Standards and Control(NIBSC), the Clinical Practice ResearchDatalink (CPRD) and MHRA.
Earlier this year, Professor Sir MichaelRawlins was appointed Knight GrandCross of the Order of the British Empire(GBE) for the services to the safety ofmedicines, healthcare and innovation.
Professor Sir Michael Rawlins said:
“I am delighted to serve as the Agency’sChair for a second term. One of the joysof this job is seeing each part of theAgency continue to deliver innovativescience and protect public health.
“I am looking forward to taking on thenext challenge, as we seek to continueto play a leading role in both Europeand the world on promoting publichealth.”
Chief Executive Dr Ian Hudson said:
“Sir Mike has overseen a very successfulperiod in the Agency’s history, and I’mdelighted to see his re-appointment, aswe move into an equally crucial nextstage.
“He has been at the forefront ofinnovation, development and leadershipin the public health sector for morethan 3 decades.”
Professor Sir Michael Rawlins
26
September 2017
volume 27 | No 4PHARMACEUTICAL PHYSICIAN
CARDIFF UNIVERSITY/BRAPP:Postgraduate Course in Pharmaceutical Medicine
Entry January 2018
27
COURSE DETAILSThe PostGraduate Course inPharmaceutical Medicine (PGCPM) is a10-session, knowledge-based, taughtcourse jointly organised by BrAPP(British Association of PharmaceuticalPhysicians) and Cardiff School ofPharmacy and Pharmaceutical Sciences,Cardiff University. The Course isdesigned as an entirety and sessions arenot available on a stand-alone basis. Itprovides delegates with a broadoverview of the speciality ofpharmaceutical medicine.
The purpose of the Course is two-fold :
1) To educate physicians working for, inor no behalf of the pharmaceuticalindustry in all aspects ofpharmaceutical medicine.Understanding the drug developmentprocess is crucial for future advisors,managers and leaders.
2) To prepare candidates for theDiploma in Pharmaceutical Medicine(DPM) examination. The Coursecurriculum and that of the DPM arebased upon the syllabus developedby PharmaTrain*.
*PharmaTrain is a European/globalinitiative to improve professionaltraining.
COURSE DESCRIPTIONThe PGCPM delivers sections of thePharmatrain syllabus in nine two-daysessions over an 18-month period. The10th session is a comprehensiveRevision Module and reprises aspects ofthe Course and further preparescandidates sitting the DPM. The firstsession of the Course highlights ouraffiliation with Cardiff University, utilisesthe considerable academic expertise ofthe Cardiff School of Pharmacy andPharmaceutical Sciences, Cardiff and
CARDIFF UNIVERSITY/BRAPP:Postgraduate Course inPharmaceutical Medicine –
Entry January 2018
PHARMACEUTICAL PHYSICIAN
takes place at the University in January2018 (session dates are shown below).The remaining 8 taught sessions arethen delivered through the following 18months in Central London at adedicated and well-resourced high-specification training venue. The Courseavoids teaching during the summerperiod from mid-July to the beginningof October. Every effort is made toavoid school holidays and nationalholidays. There are no sessions in Junein any year. The Revision Session isdelivered in London in mid-July at theend of the Course and to enhance thestart of serious exam prep.
SPEAKERS AND PRESENTERSSessions are taught by a variety ofexperts in their respective fields andcrucially by a broad spectrum ofindustry professionals. Manycontributors will have first-handexperience of UK and globalpharmaceutical development, the DPMexam and are available during andbetween sessions to assist withindividual learning issues.
Session content and delivery is regularlyreviewed on an on-going basis.Delegate feedback and organisermoderation are used to enhance toquality of training.
SESSION TIMINGThe model two-day session which takesplace mid-working week (Tuesday,Wednesday or Thursday) beginsteaching at 09:00 and finish eachworking day by 17:00. (Usually Day 2finishes at 16:00 to enable European-based delegates to catchflights/Eurostar). Where possible, mostUK delegates are able attend on a dailybasis without the need for overnightaccommodation (there is no eveningsession work) and the London locationis well placed for travel connections.There are many hotels in the vicinity.
FEES & COSTSTuition Fees Part 1
(January to May 2018)
Tuition fees, payable in advance ofcommencement of teaching, £4500(GBP). This includes a £200 (GBP)
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| SESSION PLAN:
January 2018 – May 2018 (part 1)
1) Introduction, Discovery of Medicines, planning the development of amedicine
17-18 January
2) Pre-clinical testing, lead identification, toxicology and safetypharmacology
28 February-1March
3) Medical Statistics 27-28 March
4) Exploratory development: Phase 0 to IIA 25-26 April
5) Clinical Trials 23-24 May
October 2018- July 2019 (part 2)
6) Pharmacovigilance 17-18 October
7) Medicines Regulation 28-29 November
8) Information, promotion and education 6-7 March 2019
9) Legal, finance, ethics and pharmacoeconomics 8-9 May
10) Revision and Critical Appraisal 16,17,&18 July
deposit, payable at the time ofregistration and non-returnable. Tuitionfees include all PGCPM materials –handouts, folders and, of course,speaker honoraria etc. Delegates,however, may attend modules out ofsequence and out of year, should theirschedules require this. There will be nofurther tuition charges.
Venue Costs Part 1 (January to May
2018)
For each day of the session attendedthere will be a venue charge of £80.This covers venue costs – room hire,refreshments which include acontinental breakfast, tea and coffee adlib with light snacks and a 3-course low-GI hot and cold buffet lunch.
The venue costs must be paid ahead ofattendance at each session and thesecharges can be incorporated into thetuition fees invoice if more convenient.
Tuition Fees Part 2 (October 2018 – July
2019)
Tuition fees, payable in advance ofcommencement of teaching, £5400(GBP). All Course material is includedand additionally delegates attend a one-day Critical Appraisal Workshop in July
2018. Critical Appraisal comprises 50%of Paper 2 of the DPM exam and is acritical skill for all pharmaceuticalphysicians.
Venue costs for 2018-2019
Have yet to be agreed – we anticipateonly minor (if any) increase on the2017/2018 rates. BrAPP will seek tonegotiate the best rates.
PLEASE NOTE: Delegates areresponsible for their own travel andaccommodation (should any berequired).Payment methods
Payment should be made in GB Sterlingby Bank Transfer (full bank details canbe found on registration forms andinvoices) to BrAPP. Tuition fees, asabove, must be paid to enable adelegate to join the Course. Venue costsare levied before each module (unlesspaid with tuition fees) and may be paidby credit card, if preferred, to BrAPP.
PLEASE NOTE: Once a delegate hasfinalised registration/commenced Part 1or Part 2, the tuition fees for the entiretyof the five modules per year are non-fundable by BrAPP/Cardiff University.
CARDIFF UNIVERSITY/BRAPP:Postgraduate Course in
Pharmaceutical Medicine –
Entry January 2018
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