Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.

The course will also outline how variations to the marketing authorisation, as well as authorisation of specific groups of products such as orphan, paediatric, advanced therapy and herbal medicinal products are handled in the EU. The transparency of EU regulatory decision making will be demonstrated via review and navigation of EU regulatory websites. The impact of key emerging trends already affecting or likely to impact on European pharmaceutical registrations in the future will be discussed.

Who Should Attend

An experienced ex-regulator will deliver this course and provide a comprehensive overview of the regulatory filing requirements in Europe. The course will be of value to both those who are new Regulatory Affairs in the pharmaceutical, biopharmaceutical and generic drug industries, as well as experienced professionals wishing to refresh their regulatory knowledge. Personnel whose responsibilities require knowledge of the EMA and European country regulatory environment, such as Project Managers and those in Clinical, Non Clinical, Manufacturing and Quality areas will also find this training highly relevant.

Ms. Mary Rafter

Specialties: Regulatory

Mary Rafter is a pharmaceutical professional with experience across regulatory affairs, regulation of medicines, quality and scientific support. She is currently a consultant contributing to academic education programs.

Following a period in pharmaceutical quality control for Rice Steele & Co., Ms. Rafter joined the National Drugs Advisory Board (forerunner of the Irish Medicines Board) in 1983. There, she spent fourteen years as a pharmaceutical assessor. In this role, she was involved in clinical trials and the quality assessment of EU and national applications. In that time, she also developed a specialization in inhaler technologies.

In other roles, Ms. Rafter served as Technical and Marketing Services Manager for Cahill May Roberts, EU-Qualified Person in batch release with Wyeth and as Senior Regulatory Affairs Manager for Pfizer (formerly Wyeth Medica Ireland). There, her responsibilities included scientific support, training and coordination of several major regulatory projects.

She received her Bachelor of Science Degree in Pharmacy from University College Dublin and her Master's of Science Degree in Pharmaceutical Medicine from Trinity College. She also maintains her status as a registered pharmacist with the Pharmaceutical Society of Ireland.

Ms. Rafter has represented the Irish Medicines Board at CPMP/CHMP/EMEA as a pharmaceutical expert. She was also a delegate to the EU Working Party on Strategy for CFC Inhaler Phase-out and member of the EU Working Group on the Implementing Guidelines for Clinical Trials Directive.