Bringing a new pharmaceutical product from the laboratory to the pharmacy requires years of bench research, and nonclinical research to assess the safety profile of the new drug. The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with FDA, manufacturing your product in the most efficient manner compliant with the appropriate regulations, and finally assembling a high-quality application that will be accepted and approved by the FDA.
Each of these steps requires a clear focus and is time and labor intensive. Your handling of the process can potentially accelerate, delay, or derail the approval process.
Good project management and excellent communications with FDA will enable your company to ensure timelines are met. The development plans that you craft will be your roadmap to ensuring you stay on course, or seek alternate routes whenever speedbumps present themselves. This course will enable you to have an appreciation/understanding of the critical processes associated with drug development
This course will cover the following areas of new drug development and associated challenges…
This course will benefit anyone in drug development, regulatory affairs, management and project planning, pre-clinical, clinical CMC , Quality, and marketing personnel. Additionally, anyone looking for a high-level overview of “how a drug gets made” will find this course extremely valuable.
Albert Yehaskel is an independent consultant who has over 45 years of experience in the Pharmaceutical industry. He is an experienced and accomplished pharmaceutical professional with a distinguished record of achievement and success in the management of regulatory affairs.
He has worked for Lederle Laboratories (American Cyanamid) as an international CMC regulator and, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO Pharmaceuticals from pre-IND to post-NDA holding high level regulatory positons from senior director to VP positions. In 2010, Albert began to consult, where his expertise encompasses drugs, biologics and medical devices. His early career was devoted to medicinal pharmaceutical research and development in the areas of antibiotics and CNS agents.
During his regulatory career he authored, managed and directed all types of domestic and international regulatory submissions. Albert has filed and obtained approval of two electronic NDAs whose products are currently on the market. He is also well versed in the area of eCTD, having written many CMC sections in Modules 2 and 3. He has also filed numerous IND applications, amendments, supplements, Special Protocol Amendments, Labeling and other Regulatory documents with FDA.
Albert has had direct experience with over 14 different divisions at FDA (CDER, CBER, CDRH), preparing briefing documents, engaging in preparatory rehearsals and subsequently orchestrating key FDA meeting. He has successfully negotiated with FDA in the areas of stability, labeling and the Carcinogenicity Assessment Committee (CAC).
Albert has built, managed and mentored regulatory teams as well as creating regulatory and quality infrastructures in companies that did not have any. He has written many SOPs and provided in-house training.
Albert earned two Master degrees; a Master of Business degree in Economics and Finance from Fairleigh Dickinson University and a Master of Science degree in Organic Chemistry from Queens College, City University of New York. His Bachelor of Science degree in Chemistry was earned at the Polytechnic Institute of Brooklyn. He also served as an undergraduate instructor while pursuing his Master of Science degree, most recently taught several Regulatory Affairs modules at Stony Brook and teaches a CMC course for DIA on an annual basis.