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Parenteral Drug Association Connecting People, Science and Regulation ®

Pharmacopoeia Conference

May 29 - May 30, 2018 |
May 30, 2018 |
Renaissance Wien Hotel | Vienna, Austria
  • Conference
  • Europe
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Speaker Biographies

PDA proudly presents its inaugural conference in the topic of Pharmacopoeia.

A pharmaceutical product submitted and marketed in different countries or economic regions has to comply with the respective pharmacopoeias legally binding in those countries and regions. Typically, however, international pharmacopoeias differ in the quality requirements for the same product. Compliance, therefore, becomes a major challenge for pharmaceutical companies, resulting in the need to develop and maintain labor-intensive and costly processes.

Please join us for this inaugural PDA conference where representatives from the most relevant pharmacopoeias will share approaches to international convergence, harmonization & the future direction of pharmacopoeias with respect to the overall framework of regulations and guidelines.

Pharmaceutical industry will provide insights into their best-practices to effectively and efficiently implement international pharmacopoeial requirements.

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Tuesday, 29 May 2018

9:00
Welcome and Introduction
Falk Klar, PDA Europe
Janeen Skutnik Wilkinson, Conference Chair, Biogen
Susanne Keitel,Conference Chair, EDQM

9:15 - 13:15
Session 1: Pharmacopoeias & Their Respective Regulatory Framework
Moderator: Janeen Skutnik Wilkinson, Biogen

The role of pharmacopoeias is defined by their respective regulatory framework. In this session, we will present and discuss the current status with a panel of international representatives.

9:15
Ph. Eur. - European Pharmacopoeia
Susanne Keitel, European Directorate for the Quality of Medicines & HealthCare, EDQM

9:45
USP - United States Pharmacopoeia
Fouad Atouf, United States Pharmacopeia

10:15
JP - Japanese Pharmacopoeia
Junichi Fukuchi, Pharmaceuticals and Medical Devices Agency

10:45 – 11:15
Coffee Break, Poster Session & Exhibition

11:15
ChP - Chinese Pharmacopoeia
Colin Li, Merck KGaA

11:45
The Creation of the Pharmacopoeia of the Eurasian Economic Union (EAEU): Principles and Approaches, Integration into the International System of Drug Regulation
Ardak Tulegenova, Eurasian Economic Union, National Centre for Drug Expertiseh

12:15
Panel Discussion with International Pharmacopoeial Representatives
Trivedi Manisha Niranjanbhai, Indian Pharmaceutical Commission
Eric Karikari-Boateng, Ghana FDA

13:15 – 14:15
Lunch Break, Poster Session & Exhibition

14:15 - 18:00
Session 2: Industry Perspectives and Interactions with Pharmacopoeias
Moderator: Karen Ginsbury, PCI Pharma

This session will feature working principles of interaction and cooperation between Pharmacopoeias and representatives of some of the relevant industry stakeholders.

14:15
Industry Perspective on Collaboration with Pharmacopoeias – Case Studies
Anne Munk Jespersen, Novo Nordisk

14:45
Collaborations with Pharmacopoeia: Establishing Procedures to Accommodate Advancing Technology
Linda Narhi, Amgen for IFPMA

15:15 – 15:45
Coffee Break, Poster Session & Exhibition

15:45
Adventures in Compliance: Converging on Global Regulatory and Compendial Standards for Drug Substances and Products
Mark Wiggins, MSD

16:15
Compliance with the Spectrum of Global Pharmacopoeia
Paolo Tozzi, Novartis

16:45
The Russian Pharmacopoeia – An Industry Perspective
Elizabeth Meyers, Amgen

17:15
Q & A, Discussion

18:00
End of Day & Networking Event in Vienna

19:00
Networking Dinner in Vienna

Wednesday, 30 May 2018

9:00
Welcome and Introduction
Janeen Skutnik Wilkinson, Biogen, Conference Chair
Susanne Keitel, EDQM, Conference Chair

9:05 - 13:00
Session 3: Harmonization & Convergence Initiative
Moderator: Susanne Keitel, EDQM

This session will cover current harmonization and convergence initiatives, including the Pharmacopoeial Discussion Group, the development of Good Pharmacopoeial Practices and bilateral agreements.

9:05
The Pharmacopoeial Discussion Group (PDG)
Kevin Moore, USP

9:35
The WHO's International Meeting of World Pharmacopoeias (IMWP) and Good Pharmacopoeial Practices (GPhP)
Francoir-Xavier Lery, WHO

10:05
Global Harmonization, Good Pharmacopoeial Practices
Erin Wang, Eli Lilly

10:35
Compendial Challenges for Excipients in a Global Environment
Janeen Skutnik Wilkinsong, Biogen, on behalf of IPEC

11:05 – 11:35
Coffee Break, Poster Session & Exhibition

11:35
Compendial Methods: Industry Challenges and the Potential Impact to Supply and Patients
Stephanie Ajaj, Amgen

12:05
Compliance with Excipients and General Chapters: the Industry Point of View
Paolo Tozzi, Novartis on behalf of Efpia

12:35
Q & A, Discussion

13:00 – 14:00
Lunch Break, Poster Session & Exhibition

14:00 - 17:00
Session 4: Involving Pharmacopoeias in Scientific and Technological Developments
Brad Jordan, Amgen

In this session, we will focus on the pharmacopoeial activities such as monographs and standard setting.

14:00
Pharmacopoeial Activities Supporting Operational Flexibility and the Concept of QbD
Cathie Vielle, EDQM

14:30
Biologics, Advanced Therapies, and Future Directions in Pharmacopoeia
Alistair Gibb, MHRA

15:00 – 15:30
Coffee Break, Poster Session & Exhibition

15:30
Product Specific Monographs for Biotherapeutic Products - Industry Perspective
Earl Dye, Genentech

16:00
European Pharmacopoeia Texts on Biotherapeutic Products
Emmanuelle Charton, EDQM

16:30
Summary & Q&A

17:00
Closing & End of Conference

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).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 8 April 2018
1.395 Euro

After 8 April 2018
1.595 Euro

Nonmember

By 8 April 2018
1.695 Euro

After 8 April 2018
1.895 Euro

Govern./Health Authority/Academic

By 8 April 2018
700 Euro

After 8 April 2018
800 Euro

All fees given in Euro and excluding VAT (20%)

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

Renaissance Wien Hotel
Linke Wienzeile/Ullmannstrasse 71
1150 Vienna
Austria
Tel: +43-1-891020
Hotel Website

Experience eminent style at Renaissance Wien Hotel. The recent renovation celebrates modernity throughout the facilities. Set in the exciting city center of Vienna, Austria, the hotel features 305 spacious guest rooms with plush bedding and fashionable decor, high-speed Wi-Fi access and 24-hour room service.

The sleek bathrooms boast rain showers and deluxe amenities. Stop by the modern fitness center and sauna to rejuvenate and relax. Dine at Wunderkammer Drinking & Dining restaurant where you'll discover global cuisine, a bountiful Sunday brunch buffet, evening cocktails and lively music.

The proximity to the metro station and U-Bahn subway makes getting around Vienna, Austria easy. Stadthalle Wien, Schönbrunn Palace, the Vienna State Opera House and Mariahilferstrasse are just moments from the luxury hotel. Let the staff make your visit to Vienna memorable with our 4-star service here at Renaissance Wien Hotel.

PDA Europe has reserved a limited number of rooms until the 30th April 2018.
Book your room for the PDA Group Rate.

Single Room € 119 per night*
Double Room € 144 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • Inclusive Fitness and Sauna
  • VAT, Taxes and Service Charge will apply

How to Get There

Vienna International Airport – VIE
Airport Phone: +43 1 70070
Hotel direction: 14.3 miles E
This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3 EUR hourly, 25 EUR daily

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

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4052

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