2017 PROGRAMME

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REGISTER FOR BOTH THE 10th PHARMACOVIGILANCE CONFERENCE AND
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Join this unique event!

 

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Come to the Medicines for Europe 16th Regulatory and Scientific Affairs Conference to get an update on recent regulatory developments. Learn from the best and meet the best!

Take part in intense discussions on hot topics affecting the generic medicines industry with more than 200 participants from the competent authorities and well-known industry experts.

 

 

videorac More than 60 representatives from the competent authorities attended our regulatory conference last year.

 

Grasp this unique opportunity!

 

      Find out more Medicines for Europe events here.

 

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20160128 EGA Regulatory and Scientific Affairs Conferenc

Top Agenda topics for 2017

25 January 2017 – Pre-conference Telematics Workshop (Click here for the speaker’s Cvs)

  • ISO IDMP is around the corner: are you ready? What lies ahead?
  • Showcase: How can we best prepare for smooth implementation?

26-27 January 2017 – Regulatory and Scientific Affairs Conference

  • Looking to future patient care – a new role for the pharmaceutical sector in 2025?
  • Optimisation of regulatory operations – a way forward
  • Connecting all telematics tools to offer added value for the regulatory system – a dream or reality?
  • Data quality and integrity – how can industry and regulators collaborate to mitigate data integrity issues?
  • How to align on transparency of the global supply chain in the most efficient way and how to handle conflicts of interest?
  • Watch this space in 2017!
  • New ICH guidelines under development: BSC Biowaiver and Bioanalitycal Methods Validation
  • EU-US Trade Agreement – an opportunity for more regulatory convergence and mutual recognition?
  • Apps to accompany your medicines – how will they be regarded by the regulators?
  • Electronic product information – a future way of providing patients with information on medicinal products?

SPECIAL SESSION: Put your questions to the regulators. An opportunity to address questions to European regulators on various regulatory issues

DETAILED PROGRAMME 2017 AVAILABLE HERE

CHAIRPERSONS AND SPEAKERS

 

Pierre Meulien
Executive Director, Innovative Medicines Initiative (IMI)
Pierre MeulienExecutive Director, Innovative Medicines Initiative (IMI)
Iris Grossman, PhD
VP, Head of Personalized & Predictive Medicine, Analytics and Big Data (PPM-ABD), Global R&D, Teva
Iris Grossman, PhDVP, Head of Personalized & Predictive Medicine, Analytics and Big Data (PPM-ABD), Global R&D, Teva
Hugo Hurts
Executive Director MEB (NL)
Hugo HurtsExecutive Director MEB (NL)
Tomas Salmonson
Chair of the CHMP, MPA (SE)
Tomas SalmonsonChair of the CHMP, MPA (SE)
Kevin Horan
HPRA, (IE)
Kevin HoranHPRA, (IE)
Christa Wirthumer-Hoche, Dr. techn., Dipl. Ing.
Ages (AT)
Christa Wirthumer-Hoche, Dr. techn., Dipl. Ing.Ages (AT)
Constant van Belkum
Deputy Director, MEB (NL)
Constant van BelkumDeputy Director, MEB (NL)
Kelly Hnat
Senior Director Regulatory Information Management, Teva Pharmaceuticals
Kelly HnatSenior Director Regulatory Information Management, Teva Pharmaceuticals
Ignacio Moreno
EU Team Leader Corporate QA Audit, Apotex
Ignacio MorenoEU Team Leader Corporate QA Audit, Apotex
Stephen Vinter
Operations Manager, GLPMA and Laboratories Group, MHRA
Stephen VinterOperations Manager, GLPMA and Laboratories Group, MHRA
Susana Almeida, Dr.
Inflamax Research Inc., Canada and Co-Chair of the Bioequivalence Working Group, European Generic and Biosimilar medicines Association
Susana Almeida, Dr.Inflamax Research Inc., Canada and Co-Chair of the Bioequivalence Working Group, European Generic and Biosimilar medicines Association
Valerie Field
Interim Group Manager Regulatory, Devices Division, MHRA (UK)
Valerie FieldInterim Group Manager Regulatory, Devices Division, MHRA (UK)
Kevin Airey B.Sc (Chem), M.Sc (Pharm)
Director Regulatory Affairs EMEA Affiliates, Mylan
Kevin Airey B.Sc (Chem), M.Sc (Pharm)Director Regulatory Affairs EMEA Affiliates, Mylan
Lynne Byers
Global Head of External Supply Operations QA, Novartis
Lynne ByersGlobal Head of External Supply Operations QA, Novartis
Mark Birse
Group Manager, Inspectorate, Medicines and Healthcare products Regulatory Agency (MHRA)
Mark BirseGroup Manager, Inspectorate, Medicines and Healthcare products Regulatory Agency (MHRA)
Jean-Louis Robert
Chair QWP
Jean-Louis RobertChair QWP
Marieke Van Dalen
APIC
Marieke Van DalenAPIC
Christin Olofsson
CMDh member/Senior Expert, Medical Products Agency, Sweden
Christin OlofssonCMDh member/Senior Expert, Medical Products Agency, Sweden
Sophie Colyn
Head of Division Marketing Authorisation (DG PRE), FAMHP (BE)
Sophie ColynHead of Division Marketing Authorisation (DG PRE), FAMHP (BE)
Joan Boye
DKMA (DK)
Joan BoyeDKMA (DK)

PRE-CONFERENCE TELEMATICS WORKSHOP SPONSORS

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SPONSORS AND MEDIA PARTNERS

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CONTACT

Lucia Romagnoli
M: +44 (0) 7 562 87 68 73