QM Conference

23-24 January 2018Groot-Bijgaarden, Belgium

The Clinical Quality Management Conference

Q M

EUROPEAN CENTRE FORCLINICAL RESEARCH TRAINING

Organised by

Partnerships in Quality Management

CONFERENCE PROGRAMME

Groot-Bijgaarden(Brussels)Belgium

23-24J A N2018

You need a platform for all stakeholders involved in Clinical Quality Assurance?

The QM Conference is designed to offer this to you: it will allow to share experience, get insights from seasoned experts and above all facilitate innovation in the way the different parties work together. The first edition of the conference has “Partnerships in Quality Management” as a theme.

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Meet the Programme Committee

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Henk KamsteegJanssen

Karen SchoonisGalapagos

Dirk GilléJanssen

Catherine SkaClin-SKA sprl

Barbara HeumannGxP-Auditing

Katrien SolemeBristol-Myers Squibb

Benedikt Van NieuwenhoveECCRT

Kristel Van de VoordeBristol-Myers Squibb

Day 1: Full Programme

08:30-

09:00Welcome Coffee

09:00-

09:15Conference Opening

Kristel Van de Voorde (Bristol-Myers Squibb) & Dirk Gillé (Janssen)

09:15-

11:00

Session 1 Partnership with internal stakeholders: stakeholders owning the quality

Chair: Kistel Van de Voorde

a

How to implement a culture of owning quality?

Emmanuelle Reau (GSK Vaccines)Levina Caufriez (GSK Vaccines)

bHow do audit groups add value? Kristel Van de Voorde

(Bristol-Myers Squibb)

cHow do inspections add value? Dominique Delforge

(FAMHP)11:00

-11:30

Break

11:30-

13:00

Session 2 Partnership with academics Chair: Henk Kamsteeg

a

The Dutch Clinical Research Foundation; a partnership between academic sites, pharma, CROs and Dutch government

Henk Kamsteeg (Janssen)

bOpportunities and challenges for academic sponsors

Hilde Nevens (KCE)

cImplementing a Quality System at an academic site

Marianne van Es-Gulinck (UMC Utrecht)

13:00-

14:00Lunch

14:00-

15:30

Session 3 Partnership across pharmaceutical companies

Chair: Karen Schoonis

a

How to assure quality where IMPs are supplied by one of the co-developers whereas sponsorship of clinical trials resides with other co-developer?

Bodo Brocks (Morphosys)Koen de Backer (Galapagos)

b

How to deal with the auditing activities in a clinical development program executed by different sponsors, and during “sponsor transfer” activities?

Annegret Van der Aa (Galapagos)Karen Schoonis (Galapagos)

c

How will this look like in the future with the implementation of the “Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use” where the concept of co-sponsorship for clinical trials is introduced?

FAMHP

15:30-

16:00Break

16:00-

18:00

Session 4 CAPA management Chair: Catherine Ska

aHow to implement effective CAPA management?

Martine Lammertyn (Roche) Heidi Deluyker (Roche)

cWorkshop: How to ensure robust and effective CAPAs?

Iris Gorter de Vries (SGS)Cindy Wyns (SGS)

c Workshop: feedback and discussion All above

dClosing remarks Day 1 Kristel Van de Voorde

(Bristol-Myers Squibb) & Dirk Gillé (Janssen)

18:00-

19:00Reception

19:00-

22:00Dinner

Session 1: Partnership with internal stakeholders: stakeholders owning the qualitya. How to implement culture of owning quality?Quality should be build into the processes and everybody owns quality. But how do we build a culture of quality? How can process improvements be driven from within the operations through self-identified areas for improvement?

b. How do audit groups add value?The role of a quality audit function is evolving to become more pro-active than reactive. The audit group adds value for the stakeholders by focusing on areas that are of high risk. We will give examples of how a focus on the quality management systems can add more value and put the focus on issues that matter and improving the processes overall.

c. How do inspections add value?The Belgian Health Authority inspectors will share their expectations as to what investigator sites, vendors and sponsor should keep as documentation to be able to demonstrate compliance, in particular related to the eTMF expectations. They will share trends in inspections findings, frequent findings but also new types of issue they see.

Session 2: Partnership with academicsa. The Dutch Clinical Research Foundation; a partnership between academic sites, pharma, CROs and Dutch governmentThe amount of investigator initiated trials is increasing every year. The Clinical Trial Regulation put high demands on sites carrying out this type of research, which creates challenges and additional activities sites are not always familiar with. This session will be around the challenges sites currently struggle with.

b. Opportunities and challenges for academic sponsorsDuring this session the capacity and capabilities for the management of multi-centre trials as a non-commercial sponsor will be discussed. The presentation summarizes the assessment visits that KCE conducted at academic institutions in Belgium, which provide a nice snapshot of the Belgian landscape of academic research. The assessments focused on the capability to function as a sponsor for multi-centre randomised clinical trials within the current regulatory framework. Opportunities and challenges for academic sponsors will be highlighted.

c. Implementing a Quality System at an academic siteAssuring good quality of research performed by an academic site needs investigators and study personnel, which have expertise and who are trained in the organization of performing research projects. To help the study teams to adhere to the applicable laws and regulations in preparing and conducting clinical research, a quality system is needed in order to assure research integrity, validity of research data and to protect the rights and well-being of the subjects participating in clinical studies.

Day 1: Topics description

Session 3: Partnership across pharmaceutical companiesa. How to assure quality where IMPs are supplied by one of the co-developers whereas sponsorship of clinical trials resides with other co-developer?In this session, we will discuss whether a cross-company quality agreement ensures the necessary quality assurance mechanisms are in place and adhered to. We will take a closer look into the current regulatory setting where the sponsor is ultimately responsible for the initiation and the management of a clinical trial and the impact on the co-development setting/interactions.

b. How to deal with the auditing activities in a clinical development program executed by different sponsors, and during “sponsor transfer” activities?This topic will elaborate on the operational challenges during the set-up of a compound-specific audit plan, exchange of auditing outcomes during the conduct of the different studies, management of CAPA activities where investigator sites contribute to multiple studies managed by various sponsors, etc…

c. How will this look like in the future with the implementation of the “Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use” where the concept of co-sponsorship for clinical trials is introduced?The regulatory setting is evolving and with the implementation of the regulation on clinical trials, the different business models in which we operate will be better reflected. Will this trigger a change in defining the audit strategy of the individual co-developers since all sponsors shall have the responsibilities of a sponsor, etc…

Session 4: CAPA Managementa. How to implement effective CAPA management?Your journey to effective root cause analysis, impact analysis, CAPA evidence, CAPA effectiveness checks and CAPA management system.

b. Workshop: How to recognize efficient CAPA?

c. Workshop: feedback and discussion

Day 2: Full Programme

08:30-

09:00Welcome Coffee

09:00-

11:00

Session 5 Partnership with external service providers

Chair: Barbara Heumann

aCollaboration between sponsor company and External Service Provider auditor organizations

Christine Izzard (Janssen)

bPartner to training vendors Benedikt Van Nieuwenhove

(ECCRT)

cPartner to audit vendors Jakki Welburn (GXP-

Auditing)

dExchange of QA information through public databases

Barbara Heumann (GXP-Auditing) & Beat Widler (Widler & Schiemann AG)

11:00-

11:30Break

11:30-

13:00

Session 6 Pharmacovigilance Specific: Partnership to audit third party collaborations (internal & external)

Chair: Katrien Solome

aPartner across GxP functions for PV audits of co-developers and distributors

Helen Motamen (UCB)

bPSMF data collection in a complex big pharma environment (including partner data?)

Eleri Price-Strickland (Janssen)

cHow PV inspections can influence audit approach

Waltraud Trabe (GXP-Auditing)

13:00-

14:00Lunch

14:00-

16:00

Session 7 Future role of quality management Chair: Dirk Gillé

aImpact ICH GCP E6 (R2) / GCP Renovation

Ann Meeker-O'Connell (Janssen)

bInnovation in QM: pilot of using Smart Glasses in audits

Robby Claes (Janssen)

cTranscelerate initiatives: implementing Knowledge Management at Janssen

Erwin De Beuckelaer (Janssen)

16:00-

16:30Closing session

Glossary

CAPA: Corrective And Preventive ActioneTMF: Electronic Trial Master FileGxP: Good PracticeIMP: Investigational Medicinal ProductMAH: Marketing Authorisation HoldersPSMF: Parmacovigilance System Master FilePV: PharmacovigilanceQA: Quality AssuranceQM: Quality ManagementQMS: Quality Management System

Session 5: Partnership with external service providersa. Collaboration between sponsor company and External Service Provider auditor organizations Janssen BRQC have been outsourcing QA activities for several years. Four years ago, an initiative was launched to reduce the number of vendors we use. Previously we used the services of a number of freelance auditors, whereas now we limit our QA vendors to just two. This session will describe the range of activities that we have outsourced to these two QA partners since the start of our pilot in 2014, and will also consider the pros and cons of this way of working.

b. Partner to training vendors Staying on top of changes can be challenging in the dynamic world of clinical research. To stay compliant with the requirement of having appropriately trained teams, companies struggle to find sufficient internal resources and expertise. Working with an external training organisation can be a solution, but that solution may not be tailored enough to your needs. This talk will be about finding the right balance between keeping training in-house and going outside.

c. Partner to audit vendorsScope of services typically provided by Audit CROs, Models of collaboration from small to large size contracts, Sponsor oversight of work, Pros and Cons of outsourcing to Audit CROs.

d. Exchange of QA information through public databasesDemo of a newly launched database that allows comparison of GCP audit results in the database with own audit results in an anonymised way. Outlook to potential database development with increased data transparency. Challenges and opportunities for auditees and sponsors.

Session 6: Pharmacovigilance Specific: Partnership to audit third party collaborations (internal & external)a. Partner across GxP functions for PV audits of co-developers and distributorsCross functional GxP audits of co-development/licensing partners and distributors/local agents result in a broader coverage of the PV audit universe, as well as an efficient and holistic assessment of the QMS and GxP specific obligations and activities. In addition, it allows efficient QA resource planning and reduces the burden of audit on partners and internal stakeholders.

b. PSMF data collection in a complex big pharma environment (including partner data?)In consideration of the different types of business agreements and the rights and responsibilities transferred to partners, exchange of either the full PSMF or specific sections of the PSMF may be required to ensure MAH oversight. What would apply in case a company transferred the MA for a product not authorized in Europe? How and which data is exchanged with the partner to provide oversight on the performance of the PV System? What value could a PV audit bring during the transition phase in the event of divestments?

Day 2: Topics description

c. How pharmacovigilance inspections can influence audit approachHow PV Audit functions at pharmaceutical companies learn from PV inspection and adapt their audit approach, including access and evaluation of company specific information available to agencies.

Session 7: Future role of quality managementa. Impact ICH GCP E6 (R2) / GCP RenovationReview rationale for and anticipated impact of renovation of ICH E8 and ICH E6 R2, with a focus on the concept of clinical quality by design.

b. Innovation in QM: pilot of using Smart Glasses in auditsTechnology is more and more used in the Quality Management arena. This presentation provides an update on the use of Smart Glasses in the audit environment. The presentation will discuss some pilots that occurred to evaluate in which settings/audit types this technology might provide value.

c. Transcelerate initiatives: implementing Knowledge Management at JanssenThe goal of managing knowledge is to improve organizational performance by getting the right information to the right people at the right time. A knowledge management framework includes strategies and processes designed to identify, capture, structure, value, leverage and share the organization’s intellectual assets. The presentation will look into Transcelerate’s perspective on Knowledge management and how it is applied at BioResearch Quality and Compliance in Janssen.

QM Conference Sponsors

The Clinical Quality Management Conference

Q M

EUROPEAN CENTRE FORCLINICAL RESEARCH TRAINING

Marcel Broodthaers plein 8 - box 5, 1060 Brussels, Belgium +32 (0)2 892 40 00info@eccrt.com - www.eccrt.com

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