Regulatory Dossiers - Until recently, for each country or region, the information generated during drug development (i.e. study results, details of manufacture and legal/admin info) had to be documented in so-called regulatory dossier. This dossier was to be organized in accordance with country-specific national requirements and submitted for review by National Health Authorities. read more
 
Pharmaceutical Development - Pharmaceutical Medicine covers all aspects of Research & Development, Manufacturing, Registration, Marketing & Sales and Pharmacovigilance concerning medicinal products.

Just as in the aviation industry, the pharmaceutical industry is heavily regulated to serve customers safety. The regulation includes guidance on how to assure a consistent quality of the medicinal product and how to assess the benefit-risk ratio to the patients. read more

eCTD for Regulatory Affairs and Beyond - This course will offer insight into the regulatory environment for human pharmaceutical products, focusing particularly on EU regulatory procedures and the use of eCTDs to support worldwide registrations. Emphasis will be on understanding the multidisciplinary tasks for the preparation and maintenance of regulatory content. Read more.