01 March 2018 EMA/132201/2018 Corporate Stakeholders Department
Agenda – Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products 23 March 2018, 14:00 -16:00 Chair: Marie-Helene Pinheiro
Item
Preliminary draft agenda
1.
Welcome and introductions
2.
Time
5’
Operational preparedness for Brexit and re-allocation of UK product portfolio in the centralised procedure
15’
Update on EMA-EC Q&As and practical guidance for procedures related 3.
to Brexit for medicinal products for human and veterinary use within
15’
the framework of the centralised procedure Update on EMA Survey to Centrally Authorised Marketing
4.
Authorisation Holders to assess procedural workload resulting from
15’
"Brexit" 5.
Industry update on Brexit preparedness activities
15’
6.
Questions & Answers session
50’
7.
Close of meeting: next steps
5’
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Agenda â Industry stakeholder meeting on Brexit and operation of the
Mar 1, 2018 - the framework of the centralised procedure. 15'. 4. Update on EMA Survey to Centrally Authorised Marketing. Authorisation Holders to assess procedural workload resulting from. "Brexit". 15'. 5. Industry update on Brexit preparedness activities. 15'. 6. Questions & Answers session. 50'. 7. Close of meeting: ...
Jul 3, 2017 - 3. Strengthening the EMA support to Committees and the. Network - Zaide ... Thomas Castelnovo Head of Evaluation Procedures A Service ...
Mar 23, 2017 - on the operation of EU pharmacovigilance legislation â 3 ... in children prepared jointly with the PDCO, the EV audit milestones, MLM service, big data ... and SCOPE contribution to the EU pharmacovigilance network and.
Apr 20, 2017 - Review of experience with scientific approaches to co-development ... Implementation of the 2016 Notice on the application of the Orphan.
Jan 20, 2017 - Francois Domergue, Data Standardisation and Analytics ... Sabine Brosch, Business Lead EudraVigilance and International Standardisation in ... Esteban Herrero-Martinez, Director, Regulatory Policy & Intelligence, Abbvie.
May 19, 2017 - Advances in the co-development process for personalised medicines ... of engagement for marketing authorisation applications involving ...
In conclusion, PLEG complements pivotal randomised control trial data; and targets some remaining uncertainties. There are gaps in the workability of registries, with scope .... EMA introduced ongoing activities with regard to the implementation of n
Jan 27, 2017 - Website. Active Pharmaceutical Ingredients Committee. APIC http://apic.cefic.org/. Association of Clinical Research Organizations. ACRO.
Jun 6, 2016 - Q: Is there value in UK domestic stocks and mid-caps? ... disclosures, see the Disclosure Appendix, or go to www.gs.com/research/hedge.html.
Mr. Akihiko Tanaka, President of Japan International Cooperation Agency (JICA) ... Professor Jeffrey Sachs, Sustainable Development Solutions Network ...
Aug 16, 2016 - access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a .... Opinions on Compliance Check . ...... In these cases, a PIP is not required and it will be ...
Feb 20, 2017 - Send a question via our website www.ema.europa.eu/contact ...... Contacts of the PDCO with external parties and interaction with the Interested ..... The Medicines Company; Treatment of acute bacterial skin and skin structure ...
Jan 27, 2017 - Opinions on Compliance Check . ...... vector encoding for the human ADA gene - Orphan - EMEA-001974-PIP01-16. Pr Bobby Gaspar; Severe ...
Jan 27, 2017 - Minutes of the PCWP/HCPWP joint meeting â 20 September 2016 (EMA/625038/2016) .... 37. 9.3.4. .... T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host- .... BioCryst UK Ltd; Treatment of influenza.
Jun 6, 2016 - Distribution of ratings/investment banking relationships .... legislation, but are information and analysis not having product promotion as .... For research, models or other data available on a particular security, please contact ...
Sep 12, 2016 - updated and the Package Leaflet is proposed to be updated accordingly. ..... of a detailed analysis on a safety meta-analysis reporting a higher.
