2021 PDA Quality and Regulations Conference

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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!

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
Glenn Wright, PDA
Falk Klar, PDA Europe
Teresa Schubach, PDA Europe, Manager Programs & Events

More information coming soon.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

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,
NeuroDerm

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.

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
Updates and a Perspective on ICH Q12 Implementation in Japan Yasuhiro Kishioka,
PMDA

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.

Moderator:
Graham Cook,
Pfizer

Glenn Wright,
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 change without prior notice, all times listed in CEST

Day 2

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 Jens Ohnesorge,
Roche

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. 

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
Program Agenda subject to change without prior notice, all times listed in CEST

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