Addressing the EMA EVMPD Mandate: Insights from Pharmaceutical Company Executives

Conducted on Wednesday, 25th January 2012 at 10AM EST
 

Roundtable Abstract

The EMA has set a deadline of July 2, 2012 for companies to meet new EudraVigilance Medicinal Products Dictionary (EVMPD) reporting requirements.  For many companies, meeting this new mandate in a tight timeframe is a major undertaking. 

Virtify is sponsoring this session where senior executives from several pharmaceutical companies will discuss their specific challenges and steps they are taking to comply with this mandate. 
   
Panelists will include:

  • John W Kiser, Senior Director, Regulatory Operations, Abbott Laboratories, USA
  • Dr Jörg Lautz, Head of Application Management Group, Global Regulatory Affairs, Grünenthal GmbH, Germany
  • Gordon Topping, Associate Director, Information Strategy, Takeda Global R&D Centre (Europe), UK
  • Richard Eddershaw,  Director, Regulatory Informatics, Global Regulatory Affairs, GSK R&D, UK

Dr. Andrew Marr, Managing Director of Marr Consultancy Limited, UK and former Director of Global e-Regulatory Development in Global Regulatory Operations at GlaxoSmithKline R&D will moderate the panel.

Topics discussed may include:

  • Lessons have they learned to date as companies execute their EVMPD compliance plans
  • The big unknowns and how best to address them
  • How to organize internally to address the compliance issues and challenges
  • The extent to which companies are they relying on outside experts and service providers
  • What information systems and processes to rely on to pull together the information.

Pre registrants are encouraged to submit their own questions for the panel and questions will be accepted throughout the round table.

Panelist Bios
 

John W Kiser, Senior Director, Regulatory Operations
Abbott Laboratories, USA
John is Abbott’s project lead for their EVMPD project. He is an active member of EFPIA’s Telematics Working Group where, amongst other programs, the implementation issues of EVMPD are being considered.

DrJörgLautz, Head of Application Management Group, Global Regulatory Affairs
Grünenthal GmbH, Germany
Jörg is Grünenthal’s project lead for their EVMPD project. He has been an active member of the EU Agency/Industry group looking at the futures of electronic submissions including common portals and the next generation of eCTD.

Gordon Topping, Associate Director, Information Strategy
Takeda Global R&D Centre (Europe) Ltd, UK
Gordon is Takeda’s project lead for their EVMPD project.He is an active member of the EMA/NCA/Industry group handling the development of the Electronic Application Form.

RichardEddershaw,  Director, Regulatory Informatics, Global Regulatory Affairs
GlaxoSmithKline R&D, UK
Richard is a member of the EFPIA Telematics Working Group and has particular interest in EVMPD and Security/Digital signatures.

Dr. Andrew Marr, Managing Director of Marr Consultancy Limited
Andrew has 28 years of pharmaceutical industry experience in the areas of regulatory affairs and operations, as well as expertise with product information management. Andrew has been heavily involved-on behalf of the European Federation of Pharmaceutical Industries and Associations and the International Conference on Harmonization-in the development of International Organization for Standardization standards for identification of medicinal products. Andrew is a recognized expert in the fields of EVMPD and IDMP.

 
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