2021 PDA Quality and Regulations Conference

Name: 2021 PDA Quality and Regulations Conference
Start: 2021-10-19
End: 2021-10-20

A New Risk Landscape in an Evolving Quality and Regulatory Environment

Oct 19 - Oct 20, 2021

Central Europe Standard Time | Online

Virtual

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Europe

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Overview
Agenda
Speakers
Registration Fees
Exhibit & Sponsorship
Contact

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!

Overview

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

Agenda

Download full Agenda

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, 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

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

Highlighted Speakers

Fouad Atouf

USP

Ashley B. Boam

U.S. FDA

Bettine Boltres

West Pharmaceutical Services

Brendan Cuddy

European Medicines Agency (EMA)

Elizabeth Meyers

Amgen

Vladislav Shestakov

State Institute of Drugs and Good Practices, Russian Federation

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)	€600

All fees given in Euro, excluding VAT

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Contact

Program Inquiries

Exhibition Inquiries

Christopher Haertig

Manager Exhibition & Sponsorship

[email protected]

Course Inquiries

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]