This webinar has already taken place. Please click on the link below to watch it:

Tuesday, June 24th, 2014
11:00am – 12:00pm (EST)
Presenter: Beatriz Silva Lima, PharmD, Ph.D.

Webinar Details:

You are invited to join us for this exclusive, complimentary webinar entitled “Incorporating Safety Pharmacology Endpoints in Toxicology Studies: Transposing the Experience with Biopharmaceuticals Into Small Molecules?”.

The ICH S7A guideline, dated 2001, describes the incorporation of Safety Pharmacology in toxicology studies for biopharmaceuticals. And, in ICH M3R2, dated 2009, safety pharmacology is incorporated in such a manner that the principles could also be applied to small molecules.

In this webinar, the need for stand-alone studies will be discussed, based on the progress and experience gained in the last decade. Dr. Silva Lima will also discuss whether ICH S7 guidelines need to be revisited or not, based on the underlying flexibility, with regards to conducting safety pharmacology studies.

Don’t wait, register now for this informative and thought-provoking webinar!

 

Presenter: Beatriz Silva Lima, PharmD, Ph.D.
· Professor of Pharmacology, University of Lisbon, Portugal
· NDA Advisory Board Member
· Chair of the Scientific Committee of the Innovative Medicines Initiative (IMI)
· Former Chair of the Safety Working Party (SWP), EMA
· Former Co-Deputy in ICH discussions on ICH M3R2 and S6R1 guidelines on behalf of the European Commission
· Former member of the EMA: Committee of Human Medicines (CHMP), Committee of Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP)

 

Moderator: Dawn Van Dam
President and CEO
One Million Solutions in Health