FDAnews Announces — Pharmacovigilance in the EU: Expert Guidance on the Latest Rules and Directives Webinar, Dec. 15, 2015

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New EU directives were put in force in 2012 and compliance has become an issue with 19 companies cited for “critical pharmacovigilance failures” last year. New directives were also recently adopted on postmarket studies as well as a rule on monitoring medical literature.

Pharmacovigilance in the EU:
Expert Guidance on the Latest Rules and Directives
Dec. 15, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/pharmacovigilanceeu

New EU directives were put in force in 2012 and compliance has become an issue. Last year saw 19 companies cited for “critical pharmacovigilance failures.” New directives were also recently adopted on postmarket studies as well as a rule on monitoring medical literature.

What can drugmakers do?

Join Elisabethann Wright, BL — partner in the Brussels, Belgium office of Hogan Lovells International — for a 90-minute session discussing current EU rules. She will cover the following issues:

  •     Periodic Safety Update Reports — what they must contain, and how frequently they must be issued
  •     Marketing authorization — the difference between getting it and renewing it
  •     The new rules on post-authorization efficacy studies
  •     The powers of the Pharmacovigilance Risk Assessment Committee and their relationship with the Committee on Human Medicinal Products
  •     The significance of the “Black Triangle”
  •     The EMA’s “GVPs” — Good Pharmacovigilance Practices —12 parts out already, 3 more expected this year

Register today and stay on top of the most recent EU pharmacovigilance directives.

Who Will Benefit:

  •     Auditors
  •     Compliance officers
  •     Consultants/service providers
  •     Data management and statistics personnel
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry
  •     Pharmaceutical and cGMP auditors
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Strategic planning and business development staff

Meet Your Instructor:
Elisabethann Wright, BL is a partner in the Brussels, Belgium office of Hogan Lovells International. Her experience is in the area of European law and has included both periods in private practice and periods working with international institutions. She focuses on European Union (EU) law relating to life sciences, with particular emphasis on pharmaceutical law, medical devices, food law and the environment.

Webinar Details:
Pharmacovigilance in the EU:
Expert Guidance on the Latest Rules and Directives
Dec. 15, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/pharmacovigilanceeu

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/pharmacovigilanceeu
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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