Dr. Silva Lima discusses whether ICH S7 guidelines need to be revisited or not, based on the underlying flexibility, with regards to conducting safety pharmacology studies.
Boston, MA (PRWEB) January 31, 2017
One Million Solutions in Health™ presents Beatriz Silva Lima, PharmD, Ph.D. discussing "Incorporating Safety Pharmacology Endpoints in Toxicology Studies: Transposing the Experience with Biopharmaceuticals Into Small Molecules" via a webinar.
Beatriz Silva Lima, PharmD, Ph.D. is an important speaker with the following credentials:
· 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)
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 is discussed, based on the progress and experience gained in the last decade. Dr. Silva Lima also discusses whether ICH S7 guidelines need to be revisited or not, based on the underlying flexibility, with regards to conducting safety pharmacology studies.
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