Agenda - Adaptive pathways workshop - European Medicines Agency
Dec 6, 2016 - early access tools. Francesca Cerreta. (EMA). 09.15-. 09.30 ... Methodological challenges and the monitoring advantage of Real World Data.
Dec 8, 2016 - trial data. > Involve stakeholders, such as HTA bodies, early in the development process .... 'big data') and represent great challenges and.
Development support and early access tools at EMA. EMA is ..... j) Is the objective to apply adaptive pathways to all marketing authorisation applications at a.
Oct 18, 2016 - Send a question via our website www.ema.europa.eu/contact ... marketing authorisation holder (MAH) to create a new registry based on a ...
Nov 30, 2017 - broader set of data which ensure privacy protection and meet the standards required to maintain ... To understand the legislation impacting clinical data sharing across two jurisdictions, drawing out differences and .... healthcare dat
4 days ago - EMA/CAT/426129/2018. Page 2/17. Table of contents. 1. Introduction. 5. 1.1. Welcome and declarations of interest of members, alternates and ...
Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. â¢. Scanning the horizon for 2016 â 2018. Peter Arlett, EMA.
Jun 18, 2018 - 27. 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of .... 5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one, EMA/OD/031/10 Glutathione-pegylated ...... Abbreviations / Acronyms.
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung
30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ... Human Medicines Research & Development Support Division.
30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the ... Human Medicines Research & Development Support Division.
Jul 7, 2017 - COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS. 2.1. Opinions ... Quality. Rapp: E. Werner .... solutions table with EMA and CVMP responses to the recommendations made by the FishMed Plus. Coalition ...
Jun 19, 2017 - and may also vary during the course of the review. ...... ViiV Healthcare UK Limited; Treatment of Human Immunodeficiency Virus ..... adjunctive administration of brivaracetam, Treatment of paediatric patients with partial.
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs â meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju
Feb 9, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. â¢. Product
Oct 23, 2017 - Page 2/61. Table of contents. 1. Introduction. 11. 1.1. Welcome and declarations of interest of members, alternates and experts .......... 11. 1.2. Agenda of the meeting on 23-26 October 2017 . ...... different database to study the ri
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina SchüÃler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g
Dec 7, 2016 - publication of clinical data (Policy 0070) and revisions to the guidance to industry â Industry Associations Webinar. 9 December 2016, 10:00 to ...
Sep 19, 2017 - 14:00-14:05. 2. Data integrity â early signal detection. - data patterns/trends in data ... 16:20-17:00. 5. Inspections of Ligand Binding Assays (in.
Nov 7, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union. Telephone ...... Visualisation of choline metabolism in malignant neoplasms ..... A paediatric investigation plan (PIP) is a dev
Jan 23, 2018 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be
Oct 24, 2017 - Application of Article 8(2) of the Orphan Regulation ..... propoxy)-phenyl]-methanone, EMA/OD/187/14 Herpes simplex type 1 virus containing.
Jun 14, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ... EMA initiatives to support and accelerate early access. 10:00 2.1 ...
