Drug Safety/Pharmacovigilance Featured Articles

  1. MHRA's Summary Of PV Systems (SPS) Document 3/26/2013

    As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. By Bart Cobert

  2. MHRA's Compliance Report 3/26/2013

    On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert

  3. EU Module 15 Safety Communications 3/26/2013

    On January 24, 2013 the EMA’s latest Good PV Practices Module 15 on Safety Communications came into force. By Bart Cobert

  4. The New EMA Protect ADR Database 3/26/2013

    On February 18, 2013 the EMA released a new Adverse Drug Reaction (ADR) database. By Bart Cobert

  5. Former Acorda Chief Medical Officer Discusses Benefits And Pitfalls Of Outsourcing 3/18/2013

    Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.

  6. Drug Safety In France & Underreporting Of AEs 2/12/2013

    There is a lively controversy underway in France right now regarding drug safety. By Bart Cobert

  7. Challenges, Prechallenges, Dechallenges And Rechallenges 2/12/2013

    This is an interesting topic for which several confusing points have arisen and which merits an in depth look. By Bart Cobert

  8. Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees 2/12/2013

    This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert

  9. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II 1/22/2013

    Continuing with the review of the key points in FDA’s guidance.  This is the second of three postings. By Bart Cobert

  10. FDA's December 2012 Guidance On IND And BA/BE Reporting – Part I 1/9/2013

    FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. By Bart Cobert