HEALTHCARE TRAINING 2021 - 6-Hour Virtual Seminar on EU Regulatory Affairs Strategy During Development of Medicinal Products
Website https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-eu-regulatory-affairs-strategy |
Edit Freely
Category HEALTHCARE TRAINING 2021
Deadline: June 24, 2021 | Date: June 24, 2021
Venue/Country: Online event, U.S.A
Updated: 2021-05-21 18:09:53 (GMT+9)
Call For Papers - CFP
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development.Orphan Medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained.Incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993, and also the EU offers a range of incentives to encourage the development of these medicines.To benefit from the incentives, sponsors intending to develop an orphan medicine must submit an application to the EMA requesting 'orphan designation' for their medicine.The application is evaluated by the EMA’s Committee for Orphan Medicinal Products (COMP), which provides its opinion on whether or not the medicine qualifies as an orphan medicine for the treatment, prevention or diagnosis of a rare disease. If the COMP issues a positive opinion, the European Commission may then grant the medicine orphan status.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.