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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Europe Revision of Annex 1

Jun 12 - Jun 12, 2017 |
Jun 12, 2017 |
Hilton Berlin | Berlin, Germany
  • Workshop
  • Europe
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Following the success of the global workshops on Annex 1 organized by PDA in 2016, this year we organize a new event in preparation to the imminent publication of the new Annex 1 Final Draft. While the 2016 workshops were focused in offering a understanding of the complete guideline document, following the chapters of Annex 1, this year the workshop will focus on interrelation and interaction of Annex 1 with components, equipment and processes used and established in the pharmaceutical industry. Furthermore the event will link Annex 1 into the current regulatory framework of other guidelines, such as ICH Q9 and Q10.

As an important highlight this year’s workshop will have a strong regulatory leadership, with representatives from MHRA and the German Agency offering a thorough update on the different regulatory perspectives. Several PDA Task Force Members will moderate the sessions, organized as round tables, collecting the audience’s thoughts and questions and presenting these to the regulators for discussion.

The workshop will open with a regulatory update and will continue in three sessions: Quality Risk Management; Contamination Control: From Cleanroom to Isolator and Contamination Control: Container Closure Systems. Every session will conclude with a panel discussion with regulators, fostering a vivid exchange between all participants. Coffee and Lunch Breaks during the day will offer plenty of opportunities for networking.

Monday, June 12, 2017

10:00
Welcome
Falk Klar, PDA Europe
Gabriele Gori,GlaxoSmithKline Vaccines

Opening: Regulatory Update: Revision of Annex 1
Moderator: Gabriele Gori, 
GlaxoSmithKline Vaccines

10:10
Regulatory Perspectives on Inspectional Findings and the Revision of the Aseptic Processing Guidance
Andrew Hopkins, MHRA

10:40
Inspector's Perspective: Needs for Annex 1 Revision
Beate Reutter, Landesamt für Soziale Dienste

11:10
Q&A, Urgent Questions for Regulators

11:20
Coffee Break & Exhibition

Session 1: Quality Risk Management for Aseptic Processing
Moderator: Vincent O'Shaughnessy,
Amgen

11:50
QRM and the Aseptic Processing Control Strategy
Kelly Waldron, Val Source

12:10
QRisk Based Process Design for a Sterile Suspension
Geert Vandenbossche,
Novartis

12:30
Roundtable Discussion: Identifying Key Questions for Regulators

12:50
Panel Discussion with Regulators

13:10
Lunch Break & Exhibition

Session 2: Contamination Control: From Cleanroom to Isolator
Moderator: Gabriele Gori, GlaxoSmithKline Vaccines

14:10
Advanced Aseptic Manufacturing with Barrier Systems - Annex 1's Impact in the Fill / Finish Process Environment
Johannes Rauschnabel, Robert Bosch GmbH

14:30
Best Practices and Lessons Learned for Demonstrating Analytical Similarity

14:50
Panel Discussion with Regulators

15:10
Coffee Break & Exhibition

Session 3: Contamination Control: Container Closure Systems
Moderator: Geert Vandenbossche,
Novartis

15:40
Meaningful Control Strategy for Container Closure Integrity
Derek Duncan,
LIGHTHOUSE

16:00
Roundtable Discussion: Identifying Key Questions for Regulators

16:20
Panel Discussion with Regulators

16:40
Summary Remarks
Falk Klar,
PDA Europe
Gabriele Gori, GlaxoSmithKline Vaccines

17:00
End of Workshop

4 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

Are you entiteld to receive a discount? Need Help?

Member

695 Euro

Nonmember

895 Euro

All fees given in Euro and excluding VAT (7%)

Contact

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

Exterior

Hilton Berlin
Mohrenstraße 30
10117 Berlin
Germany
Hotel Website

Hilton Berlin is a 5-star hotel offering a sun terrace, a winter garden and a library. Featuring traditional architecture, the hotel has been open since 1990.
It is located close to the Berlin Cathedral, the Reichstag Dom and the city center, just 1km from the Potsdamer Platz subway station. The hotel is within walking distance  of Pergamon Museum, the Concert House Berlin and the shopping malls of Friedrichstraße.

This stylish hotel comprises rooms like Leisure Dome Suite, Hilton Deluxe Hilton Guest Room and Hilton Dome Guest Room with contemporary decor and such comforts as an in-room safe, a minibar, TV, a living space and a CD player. Many rooms come with a captivating view of the cathedral. The airy rooms feature bathrooms with a bathtub, a bidet and free toiletries.

The dining options include a deluxe buffet breakfast served daily. Guests can enjoy exquisite flavors of German meals at the lounge restaurant. The cozy lobby bar features live music, a terrace and free Wi-Fi.

PDA Europe has reserved a limited number of rooms until the 30th April 2017.

Book your room for the PDA Group Rate.

Single Room € 189 per night
Double Room € 209 per night

This hotel provides a shuttle service.

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 11.9 km. About 24 to 40 min

  • Bus, Subway service, fee: € 2.7 (one way)
  • Estimated taxi fare: € 25 (one way)

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 25.2 km. About 30 to 50 min

  • Bus & Subway service, fee: € 3.5 (one way)
  • Estimated taxi fare: € 40 (one way)

Parking

On-site parking fee, inquire at the hotel desk

Photos

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
Email

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https://store.pda.org/Meetings/Login.aspx?ID=3396

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