Regulatory Affairs for Support Staff ~ Part 1

About This Course

Two days of training which can be booked individually or together. Discount available if both courses booked

INTRODUCTION

This Course provides an introduction to Support Staff in Regulatory Affairs and elsewhere about most of the basics of drug development, including information, how companies can apply for approvals in Europe and the US, dealing with the national agencies and the EMEA.

The Course will provide a concise overview of most major aspects of Regulatory Affairs, and will enable staff to perform their role more effectively. The Course covers the basics of the registration procedures and the organization of the registration files. It will cover the requirements under the New EU Medicines Legislation.

WHO SHOULD ATTEND

This course is specifically designed for personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of Regulatory Affairs in the Pharmaceutical Industry.

Topics to be covered include:

• Learn about the Drug Development Process – from Drug Discovery to Product Launch and Beyond
• Understand the background of European Law – Regulations, Directives, etc.
• Discover where you can find information on Regulatory Affairs, Approvals, Withdrawals, etc.
• What is the Centralised Procedure
• Understand the EU Clinical Trial Directive
• How to Seek Scientific Advice in Europe
• What is the Common Technical Document

With:
Ryta Kuzel
Director of Regulatory Affairs, NDA Regulatory Science Ltd

About Management Forum

Management Forum has had a portfolio of Life Science events running since 1983. We are at the cutting edge of information exchange, organising over 250 conferences, seminars and residential schools every year. All of our events are researched by our experienced course directors and designed to help you make informed decisions and remain up to date with 'need to know' business information.

Management Forum Conferences offer you the opportunity to network with colleagues in your area of business and our Seminars and Residential Schools provide an intimate, interactive environment in which to learn about the latest techniques and developments.

Take advantage of the whole range of Management Forum products to help you keep up-to-date on the latest developments within Pharmaceutical and associated industry sectors.

Management Forum's Pharmaceutical Events

have an unrivalled reputation in the industry. Topics cover all aspects of the Pharmaceutical drug development process and our portfolio is continually being developed to ensure you can keep up to date with all areas relevant to your role.