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2021 PDA Quality and Regulations Conference

A New Risk Landscape in an Evolving Quality and Regulatory Environment

May 18 - May 19, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Europe
  • Online
Program Highlights

Please review the draft two-day program for May below, out now!

Don’t miss hearing updates on international regulations and make sure to join us in May.

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Overview

Dear Colleague,

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 on May 18-19!

The conference will take place as a Virtual Event once again this year! The online platform will offer multiple options for interactions and exchange. Receive direct feedback on your questions from distiguished experts in live Q&A sessions!

By joining this two-day event, attendees will ensure to receive the most current and thorough information on recent and most important changes in the regulatory landscape.

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 the manufacture and 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 seeing you join us online!

Sincerely,

The Chairs

Vinny Browning III, Amgen
Karin Baer, Neuroderm

SCIENTIFIC PROGRAM PLANNING COMMITTEE

Vinny Browning III, Amgen - Chair
Karin Baer, Neuroderm - Chair
Graham Cook, Pfizer
Patrick Costello, Abbvie
Travis Frick, GSK
Peter Reichert, Zelect
Eva Urban, CSL Behring
Ruth Miller, PDA
Falk Klar, PDA Europe
Sylvia Becker, PDA Europe, Senior Manager Programs & Events

Agenda

  • Day 1
  • Day 2
  • Tuesday, 18 May 2021

    Module I: Welcome & International Regulatory Updates
    12:00-15:30 CEST

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

    Keynote Presentation:
    Key Developments and Learnings from the Ongoing Pandemic

    Speaker,
    invited

    Live Session Introduction:
    International Regulatory Updates

    Moderators:
    Vinny Browning III,
    Amgen

    Karin Baer,
    Neuroderm
    Update on Agency Activities Brendan Cuddy,
    European Medicines Agency
    Update on GMP Regulation and Implementation MHRA,
    invited
    Updates from USP Fouad Atouf,
    United States Pharmacopeia
    Aseptic Processes in the Production of Medicinal Products in Accordance with US FDA and the Eurasian Economic Union’s Guideline Dmitriy Rozhdestvenskiy,
    Eurasian Economic Commission
    Updates and a Perspective on ICH Q12 Implementation in Japan PMDA,
    invited

    Live Q & A, Discussion


    Break, Virtual Exhibition & Poster Session 

    15:30-16:30 CEST

    Module II: International Perspectives: Remote Inspections
    16:30-19:15 CEST

    Live Session Introduction:
    International Perspectives: Remote Inspections

    Moderator:
    Graham Cook,
    Pfizer

    Ruth Miller,
    PDA
    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,
    EDQM
    Industry Perspective: PDA Points to Consider on Remote Inspections Speaker,
    invited
    New Opportunities and Challenges in Conforming with Compliance in Inspections Stephan Roenninger,
    Amgen

    Live Q & A, Panel Discussion

    Virtual Networking Lounges
    19:15-20:00 CEST

    Meet Your Peers and Engage in Live Discussion Opportunities


    Program Agenda subject to confirmation and change without prior notice.
  • Wednesday, 19 May 2021

    Module III: Quality Control & Handling Change
    12:00-13:45 CEST

    Live Session Introduction:
    Quality Control & Handling Change

    Moderators:
    Patrick Costello,
    AbbVie

    Travis Frick,
    GSK
    FDA Guidance Update: Container Closure System and Component Changes Under Covid US FDA,
    invited

    MDR: Outstanding Questions for Drug-Device Combinations

    Speaker,
    invited
    Handling Out of Specification Test Results Elissa Hilton,
    Eli Lilly & Co.

    Live Q & A, Panel Discussion


    Break, Virtual Exhibition & Poster Session 

    13:45-15:00 CEST

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

    Live Session Introduction:
    Quality Risk Management

    Moderators:
    Eva Urban,
    CSL Behring

    Karin Baer,
    Neuroderm
    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,
    Genentech

    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

Highlighted Speakers

Karin Baer
Karin Baer
Consultant
Vinny Browning III
Vinny Browning III
Amgen

Who Should Attend

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

Registration Fees

Register Now
Registration Type Price after 21 March 2021
Virtual Member €1.595
Virtual Non-Member €1.895
Virtual Co-Viewer €99
Virtual Govern./Health Authority/Academic/
Young Professionals (Member)
€600

All fees given in Euro, excluding VAT

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