2021 PDA Quality and Regulations Conference
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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
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!
Agenda
Discover What's Happening Each Day
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: This session will review multiple updates from various Regulators around our new Risk Landscape in an Evolving Quality and Regulations Environment. |
Moderators: 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: 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: 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 |
Wednesday, 20 October 2021
Module III: Quality & Regulations in Times of a Pandemic
12:00-14:00 CEST
|
Live Session Introduction: |
Moderators: 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: |
Moderators: 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 |
Registration
Pricing Options
More information coming soon.
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
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 registration-europe@pda.org 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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Become a Sponsor and/or Exhibitor
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