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2021 QR_1988x680

2021 PDA Quality and Regulations Conference

A New Risk Landscape in an Evolving Quality and Regulatory Environment

Oct 19 - Oct 20, 2021
Central Europe Standard Time | Online
  • Virtual
  • Europe
Program Highlights

Join PDA, the Program Planning Committee and an impressive panel of speakers this Fall online and learn about the most recent updates on international regulations!

Check out the final agenda and sign up today!


Dear Colleagues,

The manufacture of drugs, drug products, and combination products is one of the most closely regulated activities in the industry. The core of Good Manufacturing Practice is defined and determined by a variety of guidelines and regulations issued and updated regularly by national and international authorities. These have direct implications for the development, manufacturing, and reliable distribution of pharmaceutical products in regular times and even more so during a pandemic.

This and more will be the focus of the 2021 PDA Quality and Regulations Conference, set to take place online 19-20 October!

By joining this two-day event, you will be presented the most current and thorough information on recent and most important changes in the regulatory landscape. Receive direct feedback on your questions from distinguished experts in live Q&A and discussion sessions!

In the era of breakthrough medicinal therapies and technologies, accelerated R&D, Lifecycle and Change Management, Knowledge and Risk Management become pivotal milestones to ensure availability of these drugs.

Dive into the new decade with PDA by exploring digital solutions in Quality and don’t miss out on learnings on Control & Risk Strategies and the latest trends!

We look forward to welcoming you online this Fall!


The Chairs

Vinny Browning III, Amgen
Karin Baer, NeuroDerm


Vinny Browning III, Amgen - Chair
Karin Baer, NeuroDerm - Chair
Graham Cook, Pfizer
Patrick Costello, AbbVie
Travis Frick, Istari Oncology
Peter Reichert, Zelect
Eva Urban, CSL Behring
Glenn Wright, PDA
Falk Klar, PDA Europe
Teresa Schubach, PDA Europe, Manager Programs & Events


  • Day 1
  • Day 2
  • Tuesday, 19 October 2021

    Module I: Welcome & International Regulatory Updates
    12:00-14:00 CEST

    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chairs Vinny Browning III, Amgen
    Karin Baer,

    Live Session Introduction:
    International Regulatory Updates

    This session will review multiple updates from various Regulators around our new Risk Landscape in an Evolving Quality and Regulations Environment.

    Vinny Browning III,

    Karin Baer,
    Update on Agency Activities Brendan Cuddy,
    European Medicines Agency
    New Regulatory Initiatives in the UK for Innovative Medicines - Innovative Licensing and Access Pathway (ILAP) & ‘Point of Care’ (POC) Manufacturing for Personalized Medicines Philip Rose,
    Updates and a Perspective on ICH Q12 Implementation in Japan Yasuhiro Kishioka,

    Live Q & A, Discussion

    Break, Exhibition & Poster Session 

    14:00 - 15:30 CEST

    Module II: International Perspectives: Remote Inspections
    15:30-18:15 CEST

    Live Session Introduction:
    International Perspectives: Remote Inspections

    The restrictions on travel associated with COVID pandemic resulted in greater use of remote/virtual GMP inspections. This session explores regulator and industry perspectives on the experiences and learnings from alternatives to on-site inspections and introduces the PDA Points To Consider paper on Remote Inspections.

    Graham Cook,

    Glenn Wright,
    Hosting Remote Inspections by Russian and EU Regulators Elizabeth Meyers, Amgen
    Russian GMP Inspectorate’s Perspective Vladislav Shestakov,
    State Institute of Drugs and Good Practices
    Conducting Remote GMP Inspections of API Manufacturers in Real Time Thomas Hecker,
    New Opportunities and Challenges in Conforming with Compliance in Inspections Stephan Roenninger,
    Industry Perspective: PDA Points to Consider on Remote Inspections Eva Urban,
    CSL Behring

    Live Q & A, Panel Discussion

    Program Agenda subject to change without prior notice, all times listed in CEST
  • Wednesday, 20 October 2021

    Module III: Quality & Regulations in Times of a Pandemic
    12:00-14:00 CEST

    Live Session Introduction:
    Quality & Regulations in Times of a Pandemic

    Patrick Costello,

    Travis Frick,
    Istari Oncology
    FDA Guidance Update: COVID-Related Quality Policies Ashley Boam,
    US FDA
    USP’s Evolving Approaches to Compendial Standards Fouad Atouf,
    United States Pharmacopeia

    Moving towards Compliance to MDR Article 117 – Many Unanswered Questions

    Bettine Boltres,
    Handling Out of Specification Test Results Jens Ohnesorge,

    Live Q & A, Panel Discussion

    Break, Exhibition & Poster Session 

    14:00-15:00 CEST

    Module IV: Quality Risk Management
    15:00-17:00 CEST

    Live Session Introduction:
    Quality Risk Management

    This session will outline Quality Risk Management covering the strategical point of view, touching upon the areas of changes of ICH Q9 as per the ICH Q9 Concept paper; providing some background, elaborating informed decision making, level of formality of risk management and will also show case studies and practical examples. 

    Eva Urban,
    CSL Behring

    Karin Baer,
    Seeking the Diamonds - From QRM to PQS Decision-Making Valerie Mulholland,
    GMP Services Ltd
    Utilization of A Quality Risk Management Approach Janmeet Anant,
    Merck KGaA
    A Holistic Approach to Virus Risk Assessment and Controls in A Drug Substance Ballroom Facility Joe Jerkins,

    Live Q & A, Discussion

    Conference Summary by the Chairs

    Vinny Browning III, Amgen
    Karin Baer, NeuroDerm

    Thank you, Chair Awards, Outlook and Farewell

    Falk Klar, PDA Europe
    Program Agenda subject to change without prior notice, all times listed in CEST

Highlighted Speakers

Fouad Atouf
Fouad Atouf
Ashley B. Boam
Ashley B. Boam
Bettine Boltres
Bettine Boltres
West Pharmaceutical Services
Brendan Cuddy
Brendan Cuddy
European Medicines Agency (EMA)
Elizabeth Meyers
Elizabeth Meyers
Vladislav  Shestakov
Vladislav Shestakov
State Institute of Drugs and Good Practices, Russian Federation
Eva M. Urban
Eva M. Urban
CSL Behring

Who Should Attend

  • Quality Assurance
  • Quality Affairs/External Affairs
  • Regulatory Affairs
  • Consultants Regulatory agency employees from international agencies Manufacturing
  • Quality Control

Registration Fees

Registration Type Price after 29 August 2021
virtual Member €1.595
virtual Non-Member €1.895
virtual Govern./Health Authority/Academic/
Young Professionals (Member)

All fees given in Euro, excluding VAT

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