PDA Manufacturing Meets Legislation Workshop 2024

Berlin, Germany
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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.

Workshop dates:
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

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

Standard Registration

Member Price

€ 1.080

Non-Member

€ 1.080

See Qualifying Criteria for Member Types.

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.

Day 1

Wednesday, 04 September 2024

13:00 | Welcome
Falk Klar, PDA

Module 1: Preparation for EMA Inspectors Working Group Dialogue
Moderator: RAQ AB Representative

Introduction to Industry-Regulators Interaction
Falk Klar, PDA

Presentation of the Submitted Topics
Workshop Speed Discussions

  • Regulatory Expectation on Artificial Intelligence in Manufacturing
  • QRM Implementation
  • Pre-Approval Inspection
  • Training Effectiveness
  • EU GMP Annex 1
  • Electronic Records in Inspections

15:20 | Networking Coffee Break

Discussion Round with Readout
RAQ AB Representatives

Summary of Selected Topics
Moderator: RAQ AB Representative

17:00 | End of Workshop Day 1

Day 2

Thursday, 05 September 2024

Module 2: Impact of Planned PFAS Ban on the Pharmaceutical Industry in Europe
Moderator: Ana Kuschel, WEST

09:00 | PFAS Materials Used in Pharmaceutical Manufacturing Settings- Potential Supply Chain Risk
Louise Loughran, Eli Lilly and Company

Overview of the PFAS Situation for their Use in Pharmaceutical Filtration, Opportunities and Risks
Alexander Mitropoulos, Merck

Considerations for Early-Stage Testing of Chemicals for PFAS Replacement
Dieter Hennecke, Fraunhofer Institut

Impact on and Options for Elastomeric Closures on the PFAS Restriction Proposal by ECHA
Bram Jongen, Datwyler

Q&A, Discussion

10:20 | Networking Coffee Break

Flipchart Activity on PFAS Risk Assessment
Invited Speakers

12:00 | Networking Lunch Break

Module 3: Challenges and Opportunities in Pharmaceutical Manufacturing in Europe
Moderators: Ursula Busse, Tigen Pharma
Bettine Boltres, WEST

13:00 | PDA’s Initiative for Early Career Professionals
Bettine Boltres, WEST

Road to Resilience: An Early Career Professional Journey
Miriam Kremer van der Kamp, Vils

Running the Pharmaceutical Packaging Race
Ana Kuschel, WEST

14:15 | Networking Coffee Break

Innovative Manufacturing Approaches in Europe: From Idea to Implementation
Ursula Busse, Tigen Pharma

EDQM Remote Inspections
Oisin Daly, EDQM

Panel Discussion

16:20 | End of Workshop Day 2

Day 3

Friday, 06 September 2024

Module 4: Overview of the Current Changes in the EU Regulatory Framework
Moderator: Stephan Rönninger, Amgen

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
Marion Briggs, Airfield Consulting

Getting to Pharma Organizational Action on Sustainability
Joachim Almdal, Green Innovation Group

Q&A, Discussion

10:00 | Networking Coffee Break

10:30 | Pharmaceutical Manufacturing in the Regulatory Framework
Stephan Rönninger, Amgen

Panel Discussion
Moderator: Stephan Rönninger, Amgen

General Pharma Legislation
Impact on CMC, manufacturing, environmental risk assessment, inspections, imported products, and supply.

‘License to Operate’
Under that term, the requirements for environmental control and sustainability are managed.

Drug Shortage Prevention
While companies and marketing authorization holders follow basic principles implementation measures by individual EU Member States and other countries may benefit from a holistic harmonized approach and identifying the real root causes.

Key Message: Call to Action
Moderator: Stephan Rönninger, Amgen

Farewell
Falk Klar, PDA

11:45 | End of Workshop

Agenda is subject to change.

Featured Presenters

Presenters

  • Veronique Davoust, DPharm

    Pfizer, Inc.

    Read Bio
  • Julian Petersen

    Head of Global Business Development Pharma, groninger & co. gmbh

    Read Bio
  • Stephan Rönninger, PhD

    Amgen Europe

    Read Bio

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
By Air Around 30 minutes by car away from the airport.
By Other Options The location is in close proximity to the central station called 'Zoologischer Garten'. It's just a two-minute walk away.
Special Deutsche Bahn Train Fares
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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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