Pharmacovigilance

A term that can be applied to the entirety of drug safety oversight, including pre-approval and post-marketing periods.

Drug Safety challenges differ substantially between early development (Phase 1, 2), late stage clinical trials (Phase 3), and the post-marketing period. As expected, these differences are reflected in the concerns of the companies responding to the survey

CLICK HERE FOR THE RESULTS OF THE IND SAFETY FINAL RULE SURVEY

These nuances are fairly well known in industry drug safety circles.

What is less known however is the impact of FDA’s recent movements with respect to the IND Safety Final Rule: the June 2021 Draft Guidance:

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.

CLICK HERE FOR GUIDANCE DOCUMENT

Dr Peg Fletcher Margaret Fletcher MD PhD

Dr. Peg Fletcher, industry recognized drug safety thought leader and driving force behind the early development drug safety CRO MedAssessment is honored to be invited by DIA to present a poster to:

European DIA Annual Meeting
29-31 March, 2022
Brussels, Belgium

CLICK HERE FOR THE RESULTS FROM OUR IND SAFETY FINAL RULE SURVEY

Among the potential impacts of the Draft Guidance are:

New requirements for analysis of aggregate safety data during active study conduct

Considerations with respect to how to include unblinded data in the aggregate analysis

Incorporation of epidemiology studies, and impact on rare disease and other indications for which
copious epidemiology data may not be available

Defining event vs. toxicity

Defining benchmarks for anticipated events

Creation of a safety surveillance plan

Dealing with different requirements for FDA vs. other global health authorities.