The regulatory affairs market has always been of a fluid nature due to the constant changes in European regulations. Regulatory adherence is imperative for obtaining and maintaining marketing authorisation.
This 3-day course will examine the current European legislation and understand the consequences these have on a Regulatory Affairs Manager. It will also compare the regulatory requirements between Europe and the rest of the world.
Once completed delegates will be fully up-to-date with the latest legislations and be equipped with the knowledge and confidence to instigate the optimisation of the in-house regulatory procedures.
There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.
Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.
Anyone working within the field of regulatory affairs at management level or above, such as: