Regulatory Affairs for QA: Marketing Authorizations Training
About This Course
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:
- Regulatory agency expectations on the data that should be included in an eCTD
- What can (and often) goes wrong when too much or the wrong information is registered
- The role of the QP/QA in managing what is registered
- New/emerging chemistry and manufacturing and controls (CMC) requirements
Key Learning Objectives
By the end of your pharmaceutical regulatory affairs training you will improve and expand your:
- Awareness and knowledge of the latest regulatory procedures and CMC requirements for major market submissions
- Knowledge on how different regulatory procedures work
- Understanding of some of the differences between EU, UK and U.S. CMC requirements
- Ability to communicate with your regulatory support functions
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.