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

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

14:30 – 15:45

15:45 – 16:15

16:15 – 16:45

16:45 – 17:00

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Agenda - European Medicines Agency - Europa EU

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 ...

81KB Sizes 22 Downloads 417 Views

Recommend Documents

Agenda - European Medicines Agency - Europa EU
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 ...

Agenda - European Medicines Agency - Europa EU
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.

Agenda - European Medicines Agency - Europa EU
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs – meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju

Agenda - European Medicines Agency - Europa EU
Jun 26, 2018 - oxadiazole-3-carboximidamide - EMEA-002072-PIP01-16-M01 . ..... Human alpha-galactosidase A - Orphan - EMEA-001828-PIP01-15-M01 .

Agenda - European Medicines Agency - Europa EU
Jul 16, 2018 - Cladribine, EMA/OD/087/17 Recombinant monoclonal antibody to sialic acid-binding Ig-like lectin 8. 2.2.6. - EMA/OD/098/18. Treatment of ...

Agenda - European Medicines Agency - Europa EU
Feb 9, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... product information. For information: Summary of opinion. 2.2. Oral explanations and list of outstanding issues. •. Product

Agenda - European Medicines Agency - Europa EU
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

Agenda - European Medicines Agency - Europa EU
17 Jan 2018 - Expert meeting on adeno-associated viral vectors, 06 September 2017, EMA, London. CAT: Martina Schüßler-Lenz. Scope: report of the meeting that took place on 6 September 2017. Action: for adoption. 7.6.3. Environmental assessment of g

Agenda - European Medicines Agency - Europa EU
Dec 7, 2016 - publication of clinical data (Policy 0070) and revisions to the guidance to industry – Industry Associations Webinar. 9 December 2016, 10:00 to ...

Agenda - European Medicines Agency - Europa EU
Sep 19, 2017 - 14:00-14:05. 2. Data integrity – early signal detection. - data patterns/trends in data ... 16:20-17:00. 5. Inspections of Ligand Binding Assays (in.

Agenda - European Medicines Agency - Europa EU
Nov 7, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone ...... Visualisation of choline metabolism in malignant neoplasms ..... A paediatric investigation plan (PIP) is a dev

Agenda - European Medicines Agency - Europa EU
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

Agenda - European Medicines Agency - Europa EU
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.

Agenda - European Medicines Agency - Europa EU
Jun 14, 2016 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ... EMA initiatives to support and accelerate early access. 10:00 2.1 ...

Agenda - European Medicines Agency - Europa EU
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 ...

Agenda - European Medicines Agency - Europa EU
o Pilot to test draft model ... Endorsement of Enpr-EMA membership criteria Mark Turner/Irmgard. Eichler ... Endorsement of newly received applications.

Agenda - European Medicines Agency - Europa EU
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

Agenda - European Medicines Agency - Europa EU
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

Agenda - European Medicines Agency - Europa EU
Nov 3, 2016 - Scope: 'Optimising the development of ATMPs to meet patient needs' ... the CAT would like to discuss with company representatives in person.

Agenda - European Medicines Agency - Europa EU
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 ...

Agenda - European Medicines Agency - Europa EU
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

Agenda - European Medicines Agency - Europa EU
Sep 20, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... 20 September 2016, 08:30hrs to 16:30hrs – meeting room: 2A.

Agenda - European Medicines Agency - Europa EU
Aug 1, 2016 - Send a question via our website www.ema.europa.eu/contact. © European ... Agenda - Developing a framework of collaboration between EMA ...

Agenda - European Medicines Agency - Europa EU
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