Understanding the New EU PV RegulationsNews & Articles
- Webcast July 18th: Streamlining a Global Life Sciences Company's … May 7, 2012 - BioPharm Systems
- Collection, Assessment and Tracking of Safety Data – The Value … May 1, 2012 - Ambrish Mathur
- Webcast May 30th : Merging Multiple Drug Safety and Pharmacovigil… April 23, 2012 - BioPharm Systems
- FDA's Draft Guidance on Drug Safety Communication and Postmarketi… March 15, 2012 - FDA press release
- Organizational Changes at CDER March 12, 2012 - Pharmaceutical Executive magazine
Ask The Experts
How will biosimilars change drug safety rules in the United States?
On February 9, 2012, the FDA issued a proposed rule to govern the development of biosimilars in the US. This call for comments follows a series of FDA…Read
Resources
- Observational Medical Outcomes…
The Observational Medical Outcomes Partnership (OMOP) is a public-private partnersh… - Mini-Sentinel
Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration… - BioPharm Systems
BioPharm Systems' safety and pharmacovigilance practice offers implementation, inte… - Drug Safety Alliance (DSA)
At Drug Safety Alliance, our sole focus is helping companies like yours ensure pati…
Forum
-
“True genius resides in the capacity for evaluation of uncertain, hazardous, and conflicting information” - Winston Churchill
May 9, 2012 - Rodney L. Lemery, MPH, PhD In last month’s BLOG post we discussed the necessity and ability of systems to prioritize safety signals in our clinical, post-mark… -
“The heavens themselves, the planets and this centre, observe degree, priority and place.” – William Shakespeare
April 20, 2012 - Rodney L. Lemery, MPH, PhD. In last month’s BLOG post we discussed the necessity and ability of systems to identify potential safety signals in our clinical, p… -
New Industry Models: The blurring lines between drug safety, regulation, and access
March 13, 2012 - Sanket Agrawal I begin this article exactly where I left off in my previous one – a quotation that “99% of future predictions will fall short of… -
Drug Safety Educational Opportunities
March 5, 2012 - Tim Denman Are you looking for a conference focused on drug safety? If you are, and you can make it to the East Coast during the early spring, C…
Multimedia
Lisa Henderson, Editorial Director of Applied Clinical Trials magazine, discusses cardiac safety assessment market trends.
Lisa Henderson, Editorial Director of Applied Clinical Trials magazine, discusses cardiac safety assessment market trends.
This webcast covers the EU's recently adopted pharmacovigilance (PV) legislation, much of will be in effect by July 2012. Best practices, tips and advice…
Joseph H. Hoffman, MD, Head of Safety Science Oncology for Roche Genentech, shares portions of his presentation from the Oncology Drug Development Forum
…
Alan Louie, PhD, Research Director at IDC Health Insights, discusses the importance of integrating drug safety solutions into the eClinical ecosystem and…
Gregory Hess, MD, MBA, MSc, Chief Medical Officer and VP Health Economics/Outcomes Research at SDI Health, discusses how robust data sets will change dru…
