PDA Manufacturing Meets Legislation Workshop 2024
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Dear Colleague,
We would like to invite you to the PDA Manufacturing Meets Legislation Workshop 2024 to take place from 04-06 September 2024 in Berlin, Germany.
This interactive workshop brings experts from the pharmaceutical industry and the legislative sector together to discuss current challenges and best practices in drug manufacturing following the latest legal regulations. The workshop provides a platform for the exchange of insights on regulatory requirements, quality standards, and compliance strategies crucial to pharmaceutical production. Participants have the opportunity to analyze case studies, develop practical solutions, and gain valuable insights from professionals in the field regarding the implementation of effective manufacturing processes in compliance with legal requirements. A focus is placed on PFAS, integrating innovative technologies and proven methods to enhance product quality while meeting regulatory standards. This workshop promotes collaboration between manufacturers, students, experts, and regulatory authorities to ensure safe, effective, and compliant drug production.
We look forward to welcoming you!
Sincerely,
The Workshop Leader
Stephan Rönninger, Amgen
SCIENTIFIC PROGRAM PLANNING COMMITTEE
- Stephan Rönninger, Amgen
- Veronique Davust, Pfizer
- Jakob Defér, Amgen
- Ana Kuschel, WEST
- Ankur Kulshresthal, BMS
- Miriam Kremer van der Kamp, Vils
- Julian Petersen, groninger
- Falk Klar, PDA Europe
- Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe
Wednesday, 04 September 2024: 13:00-17:00 CEST
Thursday, 05 September 2024: 09:00-17:00 CEST
Friday, 06 September 2024: 09:00-12:00 CEST
Program Highlights
The agenda preview is out now!
Join us at this interactive workshop featuring discussions with industry experts and regulatory authorities on challenges and solutions.
Highlighted Presenters
Key Presenters
Agenda
Discover What's Happening Each Day
Wednesday, 04 September 2024
13:00 | Welcome |
Module 1: Preparation for EMA Inspectors Working Group Dialogue |
Introduction to Industry-Regulators Interaction Presentation of the Submitted Topics
|
15:20 | Networking Coffee Break
Discussion Round with Readout |
Summary of Selected Topics |
17:00 | End of Workshop Day 1
Thursday, 05 September 2024
Module 2: Impact of Planned PFAS Ban on the Pharmaceutical Industry in Europe |
09:00 | PFAS Materials Used in Pharmaceutical Manufacturing Settings- Potential Supply Chain Risk Overview of the PFAS Situation for their Use in Pharmaceutical Filtration, Opportunities and Risks Considerations for Early-Stage Testing of Chemicals for PFAS Replacement Impact on and Options for Elastomeric Closures on the PFAS Restriction Proposal by ECHA
|
Q&A, Discussion |
10:20 | Networking Coffee Break
Flipchart Activity on PFAS Risk Assessment |
12:00 | Networking Lunch Break
Module 3: Challenges and Opportunities in Pharmaceutical Manufacturing in Europe |
13:00 | PDA’s Initiative for Early Career Professionals Road to Resilience: An Early Career Professional Journey Running the Pharmaceutical Packaging Race |
14:15 | Networking Coffee Break
Innovative Manufacturing Approaches in Europe: From Idea to Implementation EDQM Remote Inspections |
Panel Discussion |
16:20 | End of Workshop Day 2
Friday, 06 September 2024
Module 4: Overview of the Current Changes in the EU Regulatory Framework This session will provide an overview of the hot topics changing in the EU legislative framework impacting manufacturing, quality, and supply. |
09:00 I Overview of Upcoming Regulatory Changes Relating to Sustainability Getting to Pharma Organizational Action on Sustainability Q&A, Discussion |
10:00 | Networking Coffee Break
10:30 | Pharmaceutical Manufacturing in the Regulatory Framework |
Panel Discussion General Pharma Legislation ‘License to Operate’ Drug Shortage Prevention |
Key Message: Call to Action Farewell |
11:45 | End of Workshop
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Venue Details and Accommodations
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.
PDA Europe recommends the following hotels in walking distance to the event location, but there are several other hotels in this area. Please note, PDA did not reserve any rooms.
Hotel Indigo Berlin, Ku'damm
Hardenbergstrasse 15
10623 Berlin, Germany
Walking distance from event location three minutes.
Waldorf Astoria Berlin
Hardenbergstrasse 28
10623 Berlin, Germany
Walking distance from event location ten minutes.
Hampton by Hilton Berlin City West
Uhlandstrasse 188-189
10623 Berlin, Germany
Walking distance from event location around five minutes.
How to Get Here
Special Deutsche Bahn Train Fares
Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.
Event Ticket one-way and specific train (subject to availability):
- 1st class 89,90€ (seat reservation incl.)
- 2nd class 55,90€
Event Ticket one-way and fully flexible:
- 1st class 112,90€ (seat reservation incl.)
- 2nd class 77,90€
Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.
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Pricing Options
Standard Registration
Member Price
€ 1.080Non-Member
€ 1.080
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.
Presenters
Meet the Experts
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Sponsorship and Exhibit Opportunities are available!
For more information about exhibit and sponsorship opportunities, please contact:
Christopher Härtig
Manager Exhibition & Sponsorship
Email
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