FDAnews Announces — Complying With the New EMA Pharmacovigilance Rules: Filling the Obligations Without Committing Off-Label Violations Webinar, July1, 2014

Drugmakers for the first time must now report adverse drug reactions (ADRs) caused by their products in all uses, including off-label use. In a July 1, 2014 webinar, FDAnews and EU law expert Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office, will provide answers and in-depth information.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) June 23, 2014

Complying With the New EMA Pharmacovigilance Rules
Filling the Obligations Without Committing Off-Label Violations
**FDAnews Webinar**
July 1, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/EMAPharmaCovig

Drugmakers for the first time must now report adverse drug reactions (ADRs) caused by their products in all uses, including off-label use.

One major question is how drugmakers fulfill those pharmacovigilance obligations while not inadvertently supporting off-label promotion.

In a July 1, 2014 webinar, FDAnews and EU law expert Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office, will provide answers and in-depth information including:

  • Top concerns regarding the obligations imposed by the new legislation and the way they have been interpreted by the EMA and national authorities and how they will impact their company
  • Understanding the practical concerns arising from the requirement to report ADRs occurring during off-label use
  • How to respond to the potential influx of ADRs from patients
  • Ongoing implications of the new legislative obligations for companies’ pharmacovigilance systems. What companies are still struggling with and best practices for compliance.

It's always a slippery slope for drug manufacturers whenever requirements touching on off-label use are updated.

So, register for this 90-minute webinar to understand the new EMA pharmacovigilance requirements, and to ensure that the company will remain protected from any potential problems with off-label use or promotion.

Meet the Presenter:
Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office is deeply experienced in the area of European Union law. She has previously worked in private practice and with international institutions.

Who Will Benefit:

  •     Pharmacovigilance officers
  •     Drug safety officials
  •     Medical directors
  •     Compliance officers
  •     Executive management
  •     General/corporate counsel
  •     Risk management specialists
  •     Academic researchers

Webinar Details:
Complying With the New EMA Pharmacovigilance Rules
Filling the Obligations Without Committing Off-Label Violations
**FDAnews Webinar**
July 1, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/EMAPharmaCovig

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/EMAPharmaCovig    
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.