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PDA Europe Pharmaceutical Microbiology

Oct 15 - Oct 16, 2018
Berlin, Germany

The Future of Pharmaceutical Microbiology: Small World, Big Opportunities

  • Conference
  • Europe

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Program Highlights

Exciting PDA Europe News!

Keynote: Pharmaceutical Microbiology - Current and Future Challenges

We are very fortunate to have Dr. Tim Sandle, one of Europe’s leading experts in pharmaceutical microbiology, deliver this year’s keynote address. Dr. Sandle will discuss the changing and challenging environment for microbiology, including the need for novel alternative and rapid methods, single-use technologies and why it is important to separate people from our processes. He will address best practices and new opportunities for environmental monitoring, current expectations for contamination control programs and where the industry is regarding objectionable organisms. 

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Call for Abstracts

Overview

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.

Agenda

  • Day 1
  • Day 2
  • 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

  • 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

Additional Information

  • Call for Abstracts

    Call for Papers is available now!

    Download Call for Papers

    Call for Papers/Abstracts is available now.

    Download

    Abstract Submission

    Call for Papers/Abstracts is available now.

    Submit Abstract
  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Berlin Mariott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany

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Registration Fees

Regular Price

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

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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