2017 pda europe conference, exhibition particles in ... · sofitel berlin kurf rstendamm augsburger...
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26–27 September 2017 Sofitel Berlin Kurfürstendamm
Berlin | Germany
Particles in Injectables2017 PDA Europe Conference, Exhibition
pda.org/eu/particles2017
Taking place parallel to
the 10th Workshop on Monoclonal
Antibodies
The Parenteral Drug Association presents:
Dear Colleagues,
This year marks the 2nd edition of the conference on Particles in Injectables in Berlin, 26–27 September, and the 10th Anniversary of PDA Europe‘s Monoclonal Antibodies Workshop. Both events and its respective Education Program will join forces as part of the PDA Exchange meeting format. This meeting format combines two meetings in the same place, allowing the audience to swap between the two meetings and attend different sessions with just one meeting ticket.
The Particles in Injectables conference provides you with a summary of information on the risks to hu-man health associated with particulate matter. Particles can arise from many sources: foreign, intrinsic, or inherent to the product. Particulate matter, visible or subvisible, in sterile parenteral products is regarded a critical quality attribute, impacting patient safety. A session will focus on the nature and sources of these particles in parenterals and in infusion sets used in clinical studies and hospitals. The difference between particles in drugs and clinical infusions will be highlighted. Furthermore, packaging materials, such as glass vials, syringes and rubber stoppers are known to be major sources of particulate contamination. A session will discuss defects in packaging materials and strategies employed to detect and control them. Last but not least, manual inspection continues to provide the critical reference method for all compendial inspec-tion activity. Therefore, the concluding session will look at the use of particle standards to qualify manual and automated inspection systems, control of critical inspection parameters, as well as the development of an inspection method.
So register for one, get access to two & attend those topics of interest to you in either meeting!
We look forward to welcoming you to Berlin!
OVERVIEW
S C I E N T I F I C P R O G R A M P L A N N I N G C O M M I T T E E
1 Markus Lankers, rap.ID – Chair
2 John Shabushnig,Insight Pharma Consulting – Chair
3 Roman Veillon, GlaxoSmithKline
4 John Ayres, Eli Lilly
5 Irene Kraemer, Johannes Gutenberg-University
6 Volker Luibl, Pall
7 Falk Klar, PDA Europe
8 Melanie Decker, PDA Europe
1 2 3 4
5 6 7 8
CONFERENCE AGENDA
16 Aug 2017
Tuesday, 26 September 20179:00 Welcome and Introduction Kerstin Wilken, PDA Europe
Markus Lankers, rap.ID
John Shabushnig, Insight Pharma Consulting
Session 1 Regulatory and Pharmacopoeial Guidance on Particles in Parenterals
Moderator: Markus Lankers, rap.ID
Many different regulations govern the methods used to determine particles in parenterals and the limits associated with these methods. Some of these differences are regional and others are the result of varying interpretation of general guidelines. This session has been organized to provide current benchmarking and developments in this important element of the quality systems associated with parenteral medicines. This is also an excellent opportunity to discuss concerns and issues with current regulations.
9:15 Visible Particulates in Injections: A Regulatory Perspective Stephen Langille, FDA
9:45 Unique Status of mAbs in Europe, Requirements for Injectable Products
Steffen Gross, PEI
10:15 USP Activities John Shabushnig, Insight Pharma Consulting
10:45 Q & A, Discussion
11:00 Coffee Break, Poster Session & Exhibition
Session 2 Studies on Particles in Clinics, Sources of Particles Moderator: John Shabushnig, Insight Pharma Consulting
Particulate matter, visible or subvisible, in sterile parenteral products is regarded a critical quality attribute, impacting patient safety. Particles can arise from many sources foreign, intrinsic, or inherent to the product. This session discusses the nature and sources of these particles in parenterals and tools used in the clinical environment e.g. infusions sets. The differences between particles in drugs and clinical infusions will be highlighted.
11:30 Application of Bedside Filtration – a Tool to Reduce Protein Aggregates Risks Dramatically
Benjamin Werner, Ludwig Maximilian University of Munich
12:00 Product Related Particles in Drugs and Infusion Sets Markus Lankers, Rap.ID
12:30 Particulate Contaminants in Single-Use Systems: Measurement Challenges
Klaus Wormuth, Sartorius Stedim
13:00 Q & A, Discussion
13:15 Lunch Break, Poster Session & Exhibition
CONFERENCE AGENDA
Session 3 Sources of Particles, Measurements, Particle Loads Moderator: John Ayres, Eli Lilly
This session will include a review and discussion of particle types, sources, numbers and potential clinical impact. Measurement challenges and the impact of subvisible particles will be explored.
14:15 Linking Process Capability and Patient Risk to Establish SVP Acceptance Limits
John Ayres, Eli Lilly
14:45 Particles - Sources, Measurements and Considerations Hanns-Christian Mahler, LONZA
15:15 Requirements of Glass Quality of Primary Packaging Materials Uli Lösch, Universitätsspital Basel
15:45 Q & A, Discussion
16:00 Coffee Break, Poster Session & Exhibition
Session 4 Panel Discussion on Pharmaceutical Manufacturing Moderator: Markus Lankers, rap.ID
16:30 From the Perspective of a National Quality Reviewer Martine Jequier, Swiss Medic
17:00 Panel Discussion
18:00 End of Day 1
19:00 Networking Dinner
* Bavarian expression, meaning ‘it’s tapped’. At noon on the first day of Oktoberfest, the Mayor of Munich traditionally taps the first keg of beer, exclaiming the above phrase, which marks the official opening of the festival.
19:00 h - Meeting Point: Hotel Lobby 20:00 h - Hofbräu Berlin Karl-Liebknecht-Straße 30, Berlin22:00 h - End of Networking Dinner
O’zapft is*O’zapft is*
N E T W O R K I N G I N V I T A T I O N
OK TOBERFEST DINNERO KTO B ERFEST D IN N ERJoin us and your colleagues to enjoy an original Bavarian atmosphere
D I R N D L A N D L E D E R H O S´N A R E M O S T W E L C O M E F O R T H I S E V E N I N G !
CONFERENCE AGENDA
16 Aug 2017
Wednesday, 27 September 2017Session 5 Medical Impact of Particles Moderator: Roman Veillon, GlaxoSmithKline
9:00 Y-Site Compatibility of Intravenous Medications for Children Patrick Ball, University of Wolverhampton
10:00 Coffee Break, Poster Session & Exhibition
10:30 Sepsis, Systemic Inflammatory Response Syndrome (SIRS) Michael Sasse, Hannover Medical School
11:00 The Effect of In-Line Filtration to Reduce Systemic Inflammatory Response Syndrome
Oliver Baud, APHP
11:30 Interactions and Effect of Nanoparticles in the Healthyand Diseased Microvasculature
Markus Rehberg, University of Munich
12:00 Q & A, Discussion
12:30 Lunch Break, Poster Session & Exhibition
Session 6 Reducing Particle Load and Risk Mitigation, Improving the Patients Situation: Possible Strategies to Reduce Particle Load, e.g. Manufacturing, Use of Filters, Risk Assessment
Moderators: Volker Luibl, PALL
Romain Veillon, GlaxoSmithKline
Clinical guidelines for healthcare providers regarding the risk mitigation of particles vary strongly from country to country or do not exist currently. In order to establish these guidelines, it is not only critical to quantify and qualify particles that may be infused in patients but also to evaluate the consequences within different clinical scenarios and patient profiles. Eventually a global consensus will lead to patient safety based on the outcome of these studies.
13:30 In-Line Filtration Reduces Postoperative Phlebitis: A Randomized Clinical Trial on Abdominal Surgical Patients
Gianluca Villa, University of Florence
14:00 How many Particles enter the Body during Infusion Therapy Cornelia Keck, Philipps-University Marburg
14:30 Coffee Break, Poster Session & Exhibition
15:00 Are We Ready for Global Consensus on Filtration Practice? Ton van Boxtel, WoCoVa
15:30 Closing Panel Discussion
Topics:• Many Aspects In-Line Filtration in Clinical and Pharmaceuticals • Qualifications of Filters
16:30 Farewell Remarks & End of Conference
V E N U ESofitel Berlin KurfürstendammAugsburger Strasse 4110789 BerlinGermanyTel: +49 30 800 99 90sofitel-berlin-kurfuerstendamm.com
Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.
CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & [email protected] Program InquiriesSylvia [email protected] Customer CareTel: +49 30 436 55 [email protected] Program InquiriesElke von [email protected] / Sponsorship Inquiries Nadjeschda Gomez-StahlNadjeschda [email protected]
O RG A N I Z E RPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: +49 30 436 55 08-0Fax: +49 30 436 55 08-66
TO E X H I B IT:Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.
S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your
needs with your registration form. Specific questions can be directed to [email protected].
Special offer: Discounted travel with Lufthansa Group Airlines
Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lh.com/event-flight-booking and enter the access code DEZJPAJ in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.
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These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.
D I R EC TI O NS
INFORMATION
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SOFITEL BERLIN KURFÜRSTENDAMMBERLIN
Particles in Injectables26–27 September 2017 | Berlin | Germany
2 WAYS TO REGISTER
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Organizer: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany
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2 0 1 7 P D A E U R O P E C O N F E R E N C E S
19 – 20 September Pharmaceutical Freeze Drying Technology Cologne, Germany
26 – 27 September Particles in Injectables Berlin, Germany
26 – 27 September 10th Workshop on Monoclonal Antibodies Berlin, Germany
10 – 11 October Pharmaceutical Cold & Supply Chain Logistics Prague, Czech Republic
7– 8 November The Universe of Pre-filled Syringes and Injection Devices Vienna, Austria
21 – 22 November Outsourcing & Contract Manufacturing Munich, Germany
Subject to change For latest info: pda.org/pda-europe Shortlist 16 Aug 2017
Events with additional Education Program. More information – http://t1p.de/7p9z
Connecting People, Science and Regulation ® www.pda.org/pda-europe
General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 436 55 08-0Fax: +49 30 436 55 [email protected]