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Parenteral Drug Association Connecting People, Science and Regulation ®

Pharmaceutical Freeze Drying Technology

Sep 19 - Sep 20, 2017 |
Sep 20, 2017 |
Lindner Hotel City Plaza | Cologne, Germany
  • Conference
  • Europe
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Speaker Biographies

The aim of PDA Europe’s Freeze-Drying Conference is to foster an intensified and science-based discussion between experts from all areas of lyophilization: development, production, regulatory affairs and health authorities. Get in touch with these highly qualified and diverse professionals at 11th PDA Europe Pharmaceutical Freeze Drying Technology Conference in Cologne, Germany, 19 – 20 September!

During the last ten years, freeze-drying of biopharmaceuticals has become a routine procedure, yet the freeze-drying process remains complex. This meeting provides updates of various technical and regulatory aspects regarding lyophilization. Speakers from pharmaceutical industry, manufacturers and regulatory agencies share their knowledge and give insights into this process, deepening the understanding of its underlying physicochemical principles as well as explaining freeze-drying techniques and the efforts to implement them on a big scale. As an attendee of this conference, you get to know current and novel concepts of freeze-drying, and you get to connect and exchange ideas with experts and fellow attendees. The friendly yet professional atmosphere of this meeting provides abundant opportunities for networking. So come and join us in Cologne!

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Tuesday, 19 September 2017

9:00
Welcome and Introduction
Falk Klar, PDA Europe

IG Meeting Report, Outlook 2018
Yves Mayeresse, GSK

Opening Plenary

Moderator: Yves Mayeresse, GSK

9:20
Freeze Drying in the Food Industry: A Best-Practice Example for Pharma
Søren Holm Rasmussen, GEA Process Engineering

9:50
Being Prepared for Regulatory Review and Inspection of Lyophilized Products
Robert Darius, Sanofi

10:20
Quality by re-Design of a Legacy Product: Strategy, Execution and Regulatory Experience
Sasha Nicolic, Reig Jofre

10:50
Q & A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

Session 1: New Technologies & Developments

Moderator: Ingo Presser, Boehringer Ingelheim

 

11:30
Continuous Lyophilization of Unit Doses
Thomas de Beer, Ghent University

12:00
Continuous Freeze Drying
Jos Corver, RheaVita

12:30
Impact of Controlled Nucleation on Quality and Stability of Lyophilized Biologics
Thomas Bosch, Coriolis Pharma Research

13:00
Controlled Nucleation & Stability Data
Jake Luoma, Roche / Genentech

13:30
Q & A, Discussion

14:00
Lunch Break, Poster Session & Exhibition

Session 2: Product Control

Moderator: Raf de Dier, Janssen J&J

15:00
Case Study: Innovative Technology of a New FD Filling Line
Wolfgang Lau, Roche Diagnostics

15:30
Complexity of Wireless Product Temperature Measurement under Isolator Conditions
Franz Bosshammer, NNE

16:00
Process Analytics across the Manufacturing Process for Lyophilized Product
Mark Smith, Pfizer Global Supply

16:30
Optoelectronic Product Inspection prior to Freeze Drying
Tobias Werk, F. Hoffmann - La Roche

17:00
Q & A, Discussion

17:30
End of Day & Networking Dinner


Wednesday, 20 September 2017

Session 3: Scale-up & Transfer

Moderator: Jörg Lümkemann, F. Hoffmann - La Roche

9:00
Lyocycle Development and PAT-based Optimization – A Case Study including Modern Lyocycle Process Performance Qualification
Andrea Weiland, Explicat Pharma

9:30
Optimization Elements, Tech Transfer & Scale-Up
Jean-Rene Authelin, Sanofi

10:00
Lyophilization-Cycle Design for Dual Chamber Cartridges and a Method for Online Process Control: The "DCC-LyoMate" Procedure
Christoph Korpus, Merck KGaA

10:30
Q & A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

Session 4: Filling & Materials

Moderator: Julian Gitter, University of Munich

11:30
Evaluation of Collapse Temperature Modifiers for Freeze-Dried Protein Formulations
Christina Häuser, F. Hoffmann - La Roche

12:00
Lyophilization in SiO2 Vials
Christopher Weikart, SiO2 Medical

12:30
New 1° Packaging Materials for Freeze Drying
Florence Buscke, SCHOTT

13:00
Q & A, Discussion

13:30
Lunch Break, Poster Session & Exhibition

Session 5: PDA Interactive: Knowledge Meets Discussion

Moderator: Falk Klar, PDA Europe

Committee members and selected speakers will facilitate lively discussions and exchange around a choice of controversial key issues. Results will be collected and presented as a summary at the end of the day.

14:30
Roundtable Discussions:

  • Participants will rotate every 20min.
  • Each moderator will prepare a short summary of the discussions and present it to the audience

15:40
Coffee Break & Exhibition

16:00
Summary of Roundtables
Committee Members and Moderators

16:30
Closing Comments & Farewell
Falk Klar, PDA Europe

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).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 23 July 2017
1,345 Euro

After 23 July 2017
1.495 Euro

Nonmember

By 23 July 2017
1.645 Euro

After 23 July 2017
1.795 Euro

Govern./Health Authority/Academic

By 23 July 2017
670 Euro

After 23 July 2017
750 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

Lindner Hotel City Plaza
Magnusstrasse 20
50672 Cologne
Tel: +49 221 2034-700
Fax: + 49 221 2034-777
Email
Hotel Website

Located at the trendy Friesenplatz, Lindner Hotel City Plaza welcomes its guests in style with modern, sophisticated and charming elegance. You are right in the middle of the media metropolis of Cologne and can experience everything it has to offer with a welcoming touch of luxury

The elegant rooms each have a satellite TV, a seating area, and an en-suite bathroom with complimentary toiletries. WiFi is free throughout.

PDA Europe has reserved a limited number of rooms until the 3rdJuly 2017

Book your room for the PDA Group Rate by phone.
Single Room € 129 per night*
Double Room € 159 per night*

*Rates include the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • Taxes and Service will apply

How to Get There

  • Subway (0.1 km) Station: Friesenplatz – Lines: 3,4,5,12,15
  • City train (1.0 km) Station: Hansaring – Lines: S 6, S 11, S 12
  • Tram (0.1 km) Station: Friesenplatz – Lines: 3,4,5,12,15
  • Bus (0.6 km) Station: Rudolfplatz – Lines: 136, 146
  • Metro station 120 m away

Parking: € 25,00 per day

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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