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Annex 1

Revision of the EU GMP Guideline
May 17 - May 17, 2018 |
May 17, 2018 |
Crowne Plaza Dublin - Blanchardstown | Dublin, Ireland
  • Workshop
  • Europe
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The long-awaited draft of the revised Annex 1 has finally been released for discussion! The document’s content has increased significantly and the industry is eager to see which formerly missing subjects have now been included. Possible clarification on various vague topics is also highly anticipated.

A series of three conferences in Spain, Ireland and Germany will be set up by PDA Europe to cover the impact of these changes on the industry and on manufactures.

Local authorities as well as industry speakers will present their views on the revised Annex 1 and the modifications it induces.

The animated discussion arising will enable an extensive understanding of the new regulation.

Thursday, 17 May 2018

9:00
Welcome and Introduction
Falk Klar, PDA Europe
Gabriele Gori, GlaxoSmithKline Vaccines, PEI

9:10 - 11:00
Opening: Regulatory Update: Revision of Annex 1
Moderator: Gabriele Gori, GlaxoSmithKline Vaccines

9:10
Overview and Introduction into Final Draft EU GMP Annex 1
Greg McGurk, HPRA

9:40
Regulator's Perspective: Important Improvements and Developments
Beate Reutter, State Government Schleswig-Holstein

10:10
Industry's Perspective: Report on Comments prepared by PDA Task Force
Gabriele Gori, GlaxoSmithKline Vaccines

10:40
Q&A, Urgent Questions for Regulators

11:00 – 11:30
Coffee Break, Poster Session & Exhibition

11:30 - 13:00
Session 1: Barrier Technologies
Moderator: Johannes Rauschnabel, Robert Bosch GmbH

11:30
Isolators and Restricted Access Barrier Systems: Challenges and Solutions (sections 5.15 – 5.22 Annex 1)
Richard Denk, SKAN

11:45
Roundtable Discussion: Barrier Technologies

12:30
Panel Discussion with Regulators

13:00 – 14:00
Lunch Break & Exhibition

14:00 – 15:30
Session 2: Finishing of Sterile Products
Moderator: Anil Busimi, SCHOTT

14:00
Manufacturing of Sterile Products: Filtration, Fill & Finish and Sterilization (sections 8.17 – 8.68, 8.78 – 8.89 Annex 1)
Johannes Rauschnabel, Robert Bosch

14:15
Roundtable Discussion: From Filtration to Capping

15:00
Panel Discussion with Regulators>

15:30 – 16:00
Coffee Break & Exhibition

16:00 – 17:30
Session 3: Primary Containers and CCIT
Moderator: Richard Denk, SKAN

16:00
Visual Inspection and Container Closure Integrity (sections 8.18 – 8.29 Annex 1)
Johannes Rauschnabel, Robert Bosch

16:15
Roundtable Discussion: From Capping to Container Closure Integrity Testing

17:00
Panel Discussion with Regulators

17:30
Summary Remarks & End of Workshop
Gabriele Gori, GlaxoSmithKline Vaccines
Falk Klar, PDA Europe

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

895 Euro

All fees given in Euro and excluding VAT (23%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Crowne Plaza Dublin - Blanchardstown
Blanchardstown Town Centre
Blanchardstown Centre
Dublin 15, Ireland

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
E-mail

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4199

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