RA Module 2: EU Procedures and Applications - do you know the path to product approval?
Medicademy Regulatory Affairs Module 2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation. Get a solid understanding of the EU regulatory framework, the various types of applications and procedures.
Join us on September 3 - 5, 2014!
PV Module 4: Post-Marketing Surveillance
This course offers a comprehencive introduction to the elements of post-marketing surveillance. Incl. legislation and guidelines on management and reporting of adverse reactions, signal management, periodic safety update reports and risk management systems
ISO IDMP - The Deep Impact on RA, PV and Manufacturing
If you work in Regulatory Affairs, Pharmacovigilance or Manufacturing, you are likely to be impacted by the upcoming ISO standards on Medicinal Products (ISO IDMP)!
RA Module 10: Biopharmaceuticals - Quality Development and Documentation
Would you like to get in-depth knowledge about the scientific background of biologics and biotechnological products and the regulatory requirements to fulfil, in order to obtain appoval of these types of medicinal products? If yes, join us on October 6 - 8, 2014!
Drug-Device Convergence: Taking Patient Care Further
Are you and your company ready for the convergence wave? Have you realized the full potential of converging drugs and devices? And are you harvesting the opportunities?