European Regulatory Affairs course
The new ERA course will take place from September 2012 - June 2013.
• Download here the brochure 2011.
• If you want to register for the ERA course 2012-2013 you are requested to fill out the registration form.
• Please contact us if you have any questions.
The European Regulatory Affairs (ERA) course, previously given by the Institute for Pharmaceutical Business Administration (IFB), will continue with the same format and same team of well-qualified faculty, ensuring past high standards. The ERA course is developed and organised in close collaboration with the Leiden/Amsterdam Center for Drug Research, and now supported by the SIR Institute for Pharmacy Practice and Policy BV in Leiden. Considered a great success for over a decade, the ERA course is viewed by leading authorities as an established learning vehicle for professionals in regulatory affairs, both in industry and government.
The course covers three major areas:
- The scientific basis and rationale of the information on quality, safety and efficacy as required by the various registration systems available for pharma-ceutical products in Europe, in the context of other systems (FDA, ICH).
- The review of the common procedures within the European system including the Centralised and Mutual Recognition procedures, the Common Technical Document, and the like, in close interaction with regulatory bodies and key experts from the industry.
- The strategic and tactical aspects of the drug approval process in positioning of new medicinal products in the market place (SmPC, labelling, 'fourth hurdle' issues, scenarios for market entry).