This interactive pharmaceutical regulatory affairs training is a refresher course focused on the structure and content of a common technical document (CTD) and application routes specifically designed for QPs and other quality assurance (QA) professionals.
It includes real-world examples of pharmaceutical regulatory affairs procedures and data requirements for marketing authorization application (MAA)/New Drug Application (NDA) submissions in the EU, UK and U.S. and other world markets. Our course is also relevant to medicinal products containing small molecule drug substances, biologics, generics and biosimilars, drug device combinations and borderline products.
During the course, we explore:
By the end of your pharmaceutical regulatory affairs training you will improve and expand your:
Helen Erwood - Helen has been working in pharmaceutical regulatory affairs/regulatory compliance for many years; she has wide experience in the regulation of medicines, medical devices and borderline/OTC/ nanotechnology products and enjoys the challenge of dealing with something that doesn’t quite fit the current regulations. Helen is also eligible to act as a nonclinical expert for EU submissions. She regularly presents at The Organisation for Professionals in Regulatory Affairs (TOPRA) meetings and provides training within the industry on regulatory affairs.
Jason Collins – Jason is a seasoned regulatory professional who has been working in pharmaceutical regulatory affairs for more than 20 years. He has broad experience in medicines and medical device regulations, including advanced therapies, pediatric investigation plans, immunological products and radiopharmaceuticals, and site licensing support. Jason is also a keen supporter of TOPRA and is a module leader on their MSc Medical Device programme.