Date: 4 November 2019 | Time: 13:00–15:00 GMT
Overview
EU-Medicines4all allows the EMA, the World Health Organisation (WHO) and regulatory authorities in low- and middle-income countries (LMIC) to collaborate, to ensure patients in LMICs can benefit from innovative medicines for unmet needs. The EMA provides the scientific assessment of benefit–risk of such medicines in the conditions of use, with contribution from experts and regulators of target countries.
Initially used for HIV/AIDS, TB, malaria and certain vaccines, the pathway is open to all medicines of global public health interest; innovative products and generics, chemicals and biologicals, biosimilars and vaccines.
EU-Medicines4All has demonstrated its impact: medicines assessed through this pathway have been approved in more than 90 countries around the world since inception in 2004. Half of the medicines have also received EU marketing authorisations. Key benefits for pharmaceutical companies, NGOs and other product development partnerships include WHO cooperation and involvement of target-country regulators and experts.
Speaker
Dr Agnès Saint-Raymond
Head of International Affairs, Head of Portfolio Board
European Medicines Agency (EMA)
Benefits to delegates
- Learn how to use and engage with the pathway throughout the development lifecycle, from scientific advice to post-opinion
- Get practical advice on how to prepare and manage submissions, including eligibility
- Learn about regulatory and other support tools for developers of global health medicines
- Hear about pathways to support approval of centrally-approved medicines outside the EU
CPD: This webinar provides 2 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Suitable for
- Regulatory Affairs professionals who are interested in global health medicines
- Those working in the commercial or not-for-profit sector in the global health area
Pricing
Type |
Member |
Non-member |
Standard |
£70 + VAT* |
£95 + VAT* |
*VAT, if applicable, is charged at a rate of 20%
Discounted Places
A limited number of discounted places are available at the rates below for those:
- based in low income countries as defined by the World Bank
- or working for agencies, charities or NGOs.
Please email meetings@topra.org for a discount code before making your booking.
Type Member Non-member
Standard £35 + VAT* £47.50 + VAT*
*VAT, if applicable, is charged at a rate of 20%