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.
Andrew Willis has over 28 years' of experience in regulatory affairs and pharmaceutical development with specific knowledge in EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products.
Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew now works as an independent Regulatory Affairs and Pharmaceutical Development Consultant.
Anyone working within the field of regulatory affairs at management level or above, such as: