03 January 2017 EMA/624263/2016 Corporate Stakeholders Department
Agenda – EMA-Association of the European SelfMedication Industry (AESGP) annual bilateral meeting 11 January 2017, 14:00 – 17:00, Meeting Room 03-F
Chair: Marie-Helene Pinheiro Item
Topic
Time
1.
Welcome and general update on EMA priorities
14:00 – 14:05
2.
AESGP Self-Care Agenda and priorities
14:05 – 14:30
3.
4. 5.
6.
Centralised procedure & non-prescription medicines: taking stock of the last 10 years and the way forward Linking SPOR implementation and optimisation of regulatory processes Framework for interaction with the industry including AESGP feedback on participation in different EMA platforms AOB
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Jan 3, 2017 - Send a question via our website www.ema.europa.eu/contact ... Medication Industry (AESGP) annual bilateral meeting. 11 January 2017, 14:00 ...
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 ...
6 days ago - EMA/OD/103/14 Donor T lymphocytes depleted ex vivo of host alloreactive T cells using photodynamic treatment, EMA/OD/175/14 Allogeneic ...
o Pilot to test draft model ... Endorsement of Enpr-EMA membership criteria Mark Turner/Irmgard. Eichler ... Endorsement of newly received applications.
Jan 23, 2018 - HCP/patient cross-sectional survey and retrospective chart review Post Authorisation. Safety Study to evaluate the effectiveness of the Patient Alert Card for both IV and SC abatacept in a sample of EU countries. Positive Opinion adopt
Jan 8, 2018 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. ... EU referral procedures for safety reasons: urgent EU procedures 13. 2.1. ...... clinical data from st
Nov 3, 2016 - Scope: 'Optimising the development of ATMPs to meet patient needs' ... the CAT would like to discuss with company representatives in person.
Jul 7, 2017 - EMEA/V/C/002526. Rapp: G. J. Schefferlie. For adoption: CVMP assessment report on the targeted. PSUR for the period 11.02.14-31.12.16 ...
Oct 23, 2017 - under Article 107i of Directive 2001/83/EC, based on pharmacovigilance data. Action: For adoption of ..... manufacturing process; and 3) removal of the following missing information: special patient groups. Action: For .... analysis of
Jan 8, 2018 - information (RSI) adopted in July 2017. Action: For adoption of advice to CHMP. 7.2.15. Naltrexone hydrochloride, bupropion hydrochloride - MYSIMBA (CAP) -. EMEA/H/C/003687/MEA 004.4. Applicant: Orexigen Therapeutics Ireland Limited. PR