European Regulatory Affairs
Venue: Novotel Berlin-Mitte
|Event Date/Time: Jun 14, 2012||End Date/Time: Jun 15, 2012|
Learn about issues that impact successful regulatory strategy in Europe and how to harmonise the summary of product characteristics. Other topics covered include Article 30 and Article 31 referrals, supplementary protection certificate for patents, legal status of medicinal products, procedure for switching from prescription-only sale to over-the-counter (OTC) sales, legislation controlling medical devices, and the Clinical Trials Directive.