Dzeparoski, Marjan (2021) Regulatory Challenges of Complex Generics and Combination Products and how to deal with them & Developing Products that Qualify for Multiple Markets. In: Generics and Biosimilars Project, Program, and Portfolio Management Summit, virtual WHY Summits, 25-26 Feb 2021, virtual. (Unpublished)
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Abstract
A brief overview of the specificities and challenges of the new European directive on medical devices regarding combination products and how to deal with them is given, what are specific regulatory Challenges for complex generics in different regions, what are the regulatory disparities existing among regulatory agencies in US and Europe for complex generics and which are the best practises for ANDA submissions without product-specific guidance.
A brief overview of how can we develop products that qualify for different markets, how to create Strategic Alliances to develop products, B2B strategies to Break Commercialising and Marketing Barrier, how to deal with regulatory challenges in the development of products qualified for multiple markets is given.
| Item Type: | Conference or Workshop Item (Speech) |
|---|---|
| Subjects: | Medical and Health Sciences > Health sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Marjan Dzeparoski |
| Date Deposited: | 20 Jun 2023 12:24 |
| Last Modified: | 20 Jun 2023 12:24 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/31880 |
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