Exception From Informed Consent (EFIC) studies have a distinct and challenging set of regulatory guidelines. While 21 CFR 50.24 provides the regulatory framework for EFIC studies in the US, implementing these regulations in practice is not straightforward. Pharma Initiatives has experience successfully assisting our clients through the EFIC planning and execution process. In this one hour webinar, Pharma Initiatives Partners Gary Tyson and Mark Shapiro will share seven keys to success based on their experience. This will be an interactive webinar with time for questions.
Gary Tyson is an expert on clinical operations with over 30 years of experience consulting to the biopharma and CROs industry. Gary has helped clients successfully execute a range of “non-standard” studies, including Exception From Informed...
Mark Shapiro is a partner at Pharma Initiatives. For two decades he was driven growth and innovation programs in clinical research with a focus on complex and challenging clinical trials. Prior to joining Pharma Initiatives, Mr. Shapiro was SVP,...