The "6-Hour Virtual Seminar on EU Regulatory Affairs Strategy During Development of Medicinal Products" webinar has been added to ResearchAndMarkets.com's offering.
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.
Sponsors of designated orphan medicines are eligible to benefit from the incentives offered, including:
- Assistance with development of the medicine
- Reduced fees for marketing-authorisation applications
- Protection from market competition once the medicine is authorised
Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome.
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following advice from the Regulatory Authorities increases the probability of a positive outcome.
The Regulatory Authorities give scientific advice by answering questions posed by companies. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the company. It is not the role of the Regulatory Authorities to substitute the industry's responsibility for the development of their products.
Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.
Parallel scientific advice with the EMA and FDA may lead to an increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, a deeper understanding of the bases of regulatory decisions, and the opportunity to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies. Parallel scientific advice should focus primarily on important breakthrough drugs or important safety issues.
Parallel Scientific Advice procedures are conducted under the auspices of the confidentiality arrangement between the European Commission, the EMA, and FDA.
The Paediatric Regulation's main aim is to improve the health of children in Europe without subjecting children to unnecessary trials, or delaying the authorisation of medicinal products for use in adults.. Paediatric Investigation Plans are becoming increasingly important, and failure to integrate paediatric studies in the development may lead to a delay in approval.
Paediatric development has now become a more integral part of the overall development of medicinal products in the EU, with the Regulation working as a major catalyst to improve the situation for young patients.
Who Should Attend:
- Regulatory Affairs personnel involved in development of medicinal products in the EU, in particular from US companies
Key Topics Covered:
Introduction
- Elements of development regulatory affairs
- The regulatory plan
- Overview of the European Medicines Agency
Regulatory strategy and regulatory plans (including target SmPC)
- Structure of the regulatory plan
- Sources for the regulatory plan
Pricing and reimbursement
- What is Health Technology Assessment (HTA)?
- Who decides on pricing and reimbursement: the HTA bodies
Orphan medicinal products
- Rare diseases: orphan medicinal products?
- Main incentives
- Applying for orphan medicinal product designation
Scientific advice
- Why and when is scientific advice needed and useful?
- Topics for scientific advice
- Briefing document, timelines and planning: from submission to final scientific advice by CHMP
- National versus EMA
- Joint scientific advice CHMP HTA bodies: benefits and issues to consider
Paediatric development
- Research and development programme for medicines in children: Paediatric Investigation Plans
- Cases in which studies in children are not needed or will be done later: Waivers/deferrals
- What is a paediatric use marketing authorisation (PUMA)?
Advanced Therapy Medicinal Products (ATMP)
- Definitions
- Early scientific evaluation of quality and non-clinical data: Certification procedure
- Guidelines
For more information about this webinar visit https://www.researchandmarkets.com/r/p92ana
View source version on businesswire.com: https://www.businesswire.com/news/home/20220126005767/en/
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