Introduction to Regulatory Affairs

This a three day course aimed at individuals with 0 to 2 years experience and provides an overview of the basics for a professional in Regulatory Affairs to operate effectively within their Company.

Advanced Regulatory Affairs

Three day course targetted at individuals with 5 years or more experience. This course will increase overall understanding of Regulatory Strategy, further individuals conectivity to finance and business scenarios and provide an indepth process of managing regulatory procedures and regulatory affairs departments.

Regulatory Strategy

This two day course provides a thorough insight into potential strategies which can be implemented for delivering the business objectives of the Company whilst maintaining the high ethical standards expected by the industry.

CMC Sections of the CTD Dossier for Biological Products

This three day course is aimed at professionals and will cover regulartory requirements, Life Cycle changes, Drug Product and Drug Substance Sections...

Preparing and Writing the Common Technical Dossier

( Module 3)

Two day course will provide you with a clear understanding of the regulatory and technical requirements for Module 3 (CTD) of your application in major markets of European and USA markets.

Preparing and Witing the Common Technical Dossier

( Module 3 )

This more in depth three day course covers all of the above in more detail. It covers European, USA and ROW markets.

US FDA Course

This two day course provides a thorough understanding of the FDA requirements for submission of NDAs, ANDAs and 505(B)(2). It provides understanding of FDA Structure and review processes.

Clinical Study Start Up

This course provides best practice to be followed when initiating Clinical Studies and Monitoring Studies.

Clinical Monitoring

This is a one day practical course on key activities for monitoring clinical studies aimed at new recruits and people with minimum experience.

Advanced Therapeutic Medicinal Products Courses

This two day course is designed for professional interested or already working in the area of ATMPs.