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2021 QR_1988x680

2021 PDA Quality and Regulations Conference

Oct 19 - Oct 20, 2021
Berlin, Germany

A New Risk Landscape in an Evolving Quality and Regulatory Environment

  • Conference
  • Europe
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Program Highlights

The conference will be held as a hybrid event in Berlin, Germany! An additional online platform will offer various interactive options online!

Don’t miss hearing updates on international regulations and make sure to join us this Fall!

Sign up today!

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 in Berlin, Germany, 19-20 October!

The conference will take place as a hybrid event this year! In addition to the on-site event, an online platform will offer multiple options for interactions and exchange. Receive direct feedback on your questions from distinguished 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 welcomeing you online or on-site!

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, Istari Oncology
Peter Reichert, Zelect
Eva Urban, CSL Behring
Ruth Miller, PDA
Falk Klar, PDA Europe
Sylvia Becker, PDA Europe, Senior Manager Programs & Events

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Agenda

  • Day 1
  • Day 2

  • Tuesday, 19 October 2021

    Module I: Welcome & International Regulatory Updates
    12:00-14:45 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
    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,
    MHRA
    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 Yasuhiro Kishioka,
    PMDA

    Live Q & A, Discussion


    Break, Exhibition & Poster Session 
    14:45-15:30 CEST

    Module II: International Perspectives: Remote Inspections
    15:30-18:15 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
    New Opportunities and Challenges in Conforming with Compliance in Inspections Stephan Roenninger,
    Amgen
    Industry Perspective: PDA Points to Consider on Remote Inspections Eva Urban,
    CSL Behring

    Live Q & A, Panel Discussion
    Program Agenda subject to confirmation and change without prior notice.

  • 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

    Moderators:
    Patrick Costello,
    AbbVie

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

    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

    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

Fouad Atouf
Fouad Atouf
USP
Ashley B. Boam
Ashley B. Boam
U.S. FDA
Bettine Boltres
Bettine Boltres
West Pharmaceutical Services
Brendan Cuddy
Brendan Cuddy
European Medicines Agency (EMA)
Elizabeth Meyers
Elizabeth Meyers
Amgen

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

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

Got a Question? We have answers

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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, Germany

How to Get Here

By Air

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By Car

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Other Options

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Directions

Registration Fees

Early Registration
Registration Type Price before 29 August 2021
Virtual Member €1.395
Virtual Non-Member €1.695
Virtual Co-Viewer €99
Virtual Govern./Health Authority/Academic/
Young Professionals (Member)		 €600

All fees given in Euro, excluding VAT

Regular Registration
Registration Type Price after 29 August 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

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900 ext. 115
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