Anne Chiplin is an accomplished pharmaceutical professional with 15 years of biopharmaceutical/CRO industry experience in addition to 14 years of pharmacy management experience. She possesses a strong scientific and medical knowledge base and has an excellent understanding of good pharmacovigilance practices and current worldwide drug-safety reporting regulations. Anne gained her pharmacy degree at Nottingham University in England, and has worked in retail pharmacy, Sponsor company and CRO settings.
Anne has a thorough working knowledge of clinical trial design, the IND/NDA process and GCP/ICH guidelines. She is currently Director of Safety Evaluation and Risk Management at Intercept Pharmaceuticals in San Diego. She has experience in clinical trial and post-marketing safety report management, data review and development of aggregate safety reports, transitioning of safety database systems, and experiencing the growth from a pre-market to a marketed product/company environment. She currently oversees signal management and risk management activities for Intercept, coordinating aggregate safety reports, and contributes to regulatory and clinical documents including Investigational Brochures, Clinical Study Reports, Informed Consent Forms, Case Report Forms, Development Safety Update Reports, IND/NDA submission documents, and responses to regulatory authority inquiries.