6-Hour Virtual Seminar

6-Hour Virtual Seminar on EU Regulatory Affairs strategy during development of medicinal products

Product Id : 10626
Adriaan Fruijtier

Price Details +

$495.00 Recorded
$845.00 Corporate Recorded
Refund Policy

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview

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.

Several incentives for the development of medicines for children are available in the EU and in Member States:
Many of the products currently in development are Advanced Therapy Medicinal Products, and special considerations for the products must be considered.

Why you should attend

This seminar is specifically designed for personnel in the pharmaceutical and biotech industries who need to understand the regulatory issues involved in the development of new medicinal products within the European Union.

Upon completion of the program, participants will be able to create a comprehensive regulatory plan. All regulatory aspects to ensure a smooth development will be discussed, including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.

Designation as an orphan medicinal product in the EU has important advantages. Sponsors who obtain orphan designation benefit from a number of incentives. Therefore, it is important for companies to know the process for designation.

In this Webinar the process for obtaining designation is explained in detail. There are many factors to consider when preparing an application and taking those into account will ensure a smooth process.

Practical experience with the process (for instance about pre-submission meetings and the role of the Committee for Orphan Medicinal Products) is discussed and very valuable when preparing an application.

It is also important to be aware of the activities after orphan designation.

Choosing the right procedure for scientific advice (at the European Medicines Agency or at the National Authorities in the EU) and preparing well for the procedure is very important to assure your development program meets the requirements of the Regulatory Authorities.

This webinar will address which procedure is best depending on the circumstances, and how to choose among the National Authorities. In addition, it will cover the preparation of the meeting (including briefing document).

Additionally, the topic of how to integrate paediatric studies in the development plan will be discussed along with information regarding the special regulatory aspects of Advanced Therapy Medicinal Products.

Who Will Benefit

  • Regulatory Affairs personnel involved in development of medicinal products in the EU, in particular from US companies

Agenda

  • 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

Speaker Profile


Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.

He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom

He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.