Fondazione Gianni Benzi has launched its new e-learning course entitled ‘Marketing a drug for human use in Europe’. The Course deals with the procedures to be followed in order to obtain a Marketing Authorisation according to European rules, with particular focus on:
- Advanced Therapies Medicinal Products (ATMPs)
ATMPs are the newest challenge in the pharma world. But if the therapy is ‘advanced’, the rules for marketing this type of product are stronger!
- Orphan drugs
The development process for marketing a medicinal product for rare diseases is challenging. But if the drug satisfies a series of requirements, it gains the ‘orphan’ designation, and companies receive incentives in order to rewards their efforts.
- Paediatric medicines
Children are entitled to be treated with high-quality medicines as well as adults. Thanks to the Paediatric Regulation, the procedures for marketing medicinal products for children has been put in law and now paediatric medicines shall comply with a series of requirements in order to be named ‘a paediatric drug’.
The course is completely online and consists of 8-hour lesson structured in 4 modules. Each module is constituted by a PowerPoint presentation supported by audio comments. The text with the explanation of each slide is available both in English and in Italian language. All materials can be viewed online or saved by the user on the computer.
The course applies for 12 Italian ECM credits for all healthcare professionals, including biologists, pharmacists and physicians and is available on the Gianni Benzi Foundation e-learning platform: www.e-learning.benzifoundation.org.
For further information please visit our e-learning platform or contact us (by phone: +39.080.9643146 – 080.4670430; e-mail: rp@benzifoundation.org).