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PDA Europe Pharmaceutical Microbiology

The Future of Pharmaceutical Microbiology: Small World, Big Opportunities
Oct 15 - Oct 16, 2018 |
Oct 16, 2018 |
Berlin Mariott Hotel | Berlin, Germany
  • Conference
  • Europe
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Pharmaceutical Microbiology is an essential part of any aseptic manufacturing process. Environmental monitoring, bioburden control and sterility testing are key elements that must be considered in terms of securing product quality.

Microbiology is not only essentially important in terms of product sterility, it also plays a major role in manufacturing medical products. Crucial medicines are made of microbiological products, for example vaccines, antibiotics and hormones. Complex manufacturing processes, such as fermentation or cell culture are used in production. These products represent an on-going challenge that shapes the future of medicine.

The PDA Pharmaceutical Microbiology conference will feature presentations and case studies, accompanied by poster presentations as well as an exhibition showcasing technologies and trends in this exciting and diverse field, fostering a professional exchange amongst its participants. In 2018, this conference will be a truly global event! Taking place simultaneously in two different regions of the world, it will bring together industry, academic and regulatory experts to discuss Microbiology and its vast spectrum of possibilities.
The conference will be complemented by an extensive Education Program. Check our website for the most recent updates.

Download Call for Papers

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Monday, 15 October 2018

9:00
Welcome and Introduction

Kerstin Wilken, PDA Europe
Michael J. Miller, Microbiology Consultants, Chair
Marsha Steed, ValSource, Chair

9:00 - 9:15
Keynote: Pharmaceutical Microbiology: Current and Future Challenges
Tim Sandle, Bio Products Laboratory

OPENING PLENARY

9:45 - 11:00
Session 1: Regulatory Update
This session will provide Regulatory Perspectives on general Pharmaceutical Microbiology with special focus on microbial testing of Advanced Therapeutic Medicinal Products (ATMPs).

Moderator

Heike Merget-Millitzer, Janssen J&J

9:45
Microbiological Quality Control and Approval of Cell and Tissue Products
Isabelle Bekeredijan-Ding, Paul-Ehlich-Institut

10:15
Microbiological Quality Control – the Role of an Official Medicines Control Laboratory (OMCL) in Post-Market Surveillance Plans
Luis Soares, INFARMED

10:45
Q&A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

11:30 - 13:00
Session 2: Low Endotoxin Recovery and Pyrogen Testing
The bacterial endotoxins test (BET) is a critical requirement for injectable products and medical devices required to be pyrogen-free.  In the July-August 2018 issue of Pharmacopoeial Forum (PF), a new chapter <1085> Guidelines on the Endotoxins Test was proposed for public comment. Recently, the Japanese Pharmaceutical and Medical Device Agency published a collaborative study demonstrating equivalence between recombinant Factor C Test (rFC) and LAL. As technologies have advanced, new test methods like the rFC and Monocyte Activation Test (MAT) have been developed and made commercially available. Therefore, the goal of this session is to discuss the challenges associated with the detection and recovery of endotoxin within our industry. Finally, share lasted technology developed and implemented in routine QC analysis.

Moderator

Walid El Azab, Steris

11:30
The Changing Environment in Pyrogen and Endotoxin Testing & the PDA Technical Report: Low Endotoxin Recovery
Johannes Reich, Microcoat

12:00
LER Case Studies from a CMO Perspective
Priska Zenhäusern, LONZA Quality Control Microbiology

12:30
A Time-Saving Recombinant Horseshoe Crab Factor C Endotoxin Test Including a Novel Microplate
Gregory Devulder, bioMerieux

13:00
Q&A, Discussion

13:15
Lunch Break, Poster Session & Exhibition

SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND

14:15 - 15:15
Session 3: US Conference Opening Plenary
Imagine using your own body’s cells to cure cancer – the idea has recently been made tangible and has been shown to be successful with new discoveries in the field of immuno-oncology. CAR T (Chimeric Antigen Receptor T-Cell) therapy is a novel, cellular therapy that supercharges a patient’s own immune system T-cells and programs them to attack designated cancer cells in the body. Significant challenges with facility design, room classification, manufacturing, testing, and regulatory approval have been brought forth as several of these personalized “living drug” therapies have achieved commercialization. This opening plenary session will explore CAR T product manufacturing challenges from an industry perspective and discuss regulatory challenges for commercialization and the use of non-compendial microbiology methods.

Moderators

Kim Sobien, PETNET Solutions
Kerstin Wilken, PDA Europe

14:15
Regulatory Challenges to CAR T Commercialization
Yoko Momonoi, Regulatory CMC, Celgene,
speaking from Bethesda

14:45
FDA Perspectives on CAR T Commercialization
Kimberly L. Schultz, CBER, US FDA, Invited,
speaking from Bethesda

15:15
Questions and Answers/Discussion

15:45
Coffee Break, Poster Session & Exhibition

SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND

16:15 - 16:45
Session 4: Current Regulations in EU and US
Current regulatory and inspection trends will be the focus of this very popular session and this year we are fortunate to simulcast presentations from both European and the FDA representatives. Renowned MHRA microbiology expert and GMP inspector, Andrew Hopkins, will provide an update on the long-awaited revision to Annex 1, Manufacture of Sterile Medicinal Products. Justin Boyd, an investigator in the Office of Regulatory Affairs with FDA's Team Biologics. will present an overview of recent investigational findings and discuss some of the most significant non-compliance issues facing the industry.

Moderators

Michael J. Miller, Microbiology Consultants
Julie Barlasov-Brown, Merck & Co., Inc.

16:15
Microbiological Implications of the EU Annex 1 Revision
Andrew Hopkins, MHRA, speaking from Berlin

16:45
US Inspection Trends
Justin A. Boyd, US FDA
speaking from Bethesda

17:15
Questions and Answers/Discussion

18:00
End of Day 1 and Networking Reception

Tuesday, 16 October 2018

9:00 - 11:00
Session 5: Current Advances in Alternative and Rapid Microbiological Methods
This session will address future trends in different areas of microbial testing to improve speed, efficiency and performance of testing. The session will also provide insight into Next Generation Cell Analysis, a new non-invasive method without any sample preparation, labeling or staining.

Moderator

Heike Merget-Millitzer, Janssen J&J

9:00
Mycoplasmas in Biopharmaceutical Production Processes: Risk Assessments as Basis for Validation and Implementation of PCR Methods for Mycoplasma Safety Testing
Renate Rosengarten, Mycoplasma Biosafety Services

9:30
Evaluation of Scientific Advances to Improve the Performance of Identification Options for the Laboratory
Prasanna Khot, Charles River Labs

10:00
Label-free and Non-Invasive Single Cell Analysis Using Raman Spectroscopy
Karin Schütze, CellTool

10:30
Q&A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

11:30 - 13.30
Session 6: Contamination Control

Moderator

Marsha Steed, ValSource

11:30
Microbiological Control Strategy – Development of a Standardized Risk Assessment Tool to Enable a Harmonized Approach for Environmental Monitoring
Heike Merget-Millitzer, Cilag Janssen J&J

12:00
Moist Heat Sterilization and its Biological Validation: From Rules to Practice
Maria Luisa Bernuzzi, Fedegari Autoclavi

13:00
Case Studies of New Methods of Contamination Elimination and Prevention
Brian G. Hubka, Contamination Prevention Technologies

13:30
Lunch Break, Poster Session & Exhibition

SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND

14:30 - 16:30
Closing Plenary: Creative Solutions for Contamination Detection and Control
For this EU closing session, we will look at alternative solutions to contamination detection & control. Our two speakers are well-known on both continents for their long experience in pharmaceutical microbiology, investigations & troubleshooting, and their passion for alternative micro methods. Dr. Michael Miller will present an overview of the more recent revision of regulations and guidances to define strategies for short-shelf lives medicines such as Cell & Gene Therapy products. Jeanne Moldenhauer will focus on the infamous Burkhoderia cepacia complex and novel methods for eradication of this contamination as well as preventative measures. Those two passionate speakers will enrich their presentations with real case studies.

Moderators

Olivier Rocher, GSK Vaccines
Amy McDaniel, US FDA

14:30
Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products
Michael J. Miller, Microbiology Consultants

15:00
Case Studies with Burkholderia Cepacia Complex (BCC)
Jeanne Moldenhauer, Excellent Pharma Consulting

15:30
Questions and Answers/Discussion

16:00
Closing Comments and Farewell

16:30
End of Conference

3 Ways to register

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 26 August 2018
1.395 Euro

After 26 August 2018
1.595 Euro

Nonmember

By 26 August 2018
1.695 Euro

After 26 August 2018
1.895 Euro

Govern./Health Authority/Academic

By 26 August 2018
700 Euro

After 26 August 2018
800 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Exterior

Berlin Marriott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 14th August 2018.
Book your room for the PDA Group Rate.

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4159

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