14 June 2016 EMA/274681/2016 Stakeholders and Communication Division
Agenda - EMA Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting 14 June 2016, 09:00hrs to 13:00hrs – meeting room 3E
Co-Chairs: Isabelle Moulon (EMA) and David Haerry (PCWP) 14 June 2016
Action
08:45
Registration and reimbursement arrangements
08:55
Welcome and introduction / Health and safety information
Speaker
I. Moulon (EMA)
Disclosure of interests / Adoption of the agenda 1. PCWP activities 09:00
1.1 New PCWP mandate
For information
N. Bere (EMA)
09:10
1.2 PCWP members ‘Tour de table’
For information
All members
09:50
1.3 PCWP anniversary
For information
M. Mavris (EMA)
2. EMA initiatives to support and accelerate early access 10:00
11:15
2.1 Update on PRIME initiative
For information
J. Llinares Garcia (EMA)
2.2 Update on adaptive pathways
For information
F. Cerreta (EMA)
For information
A-S. Henry-Eude (EMA)
Coffee Break
3. Access to documents 11:30
3.1 Proactive publication of clinical study reports; redaction of commercially
and discussion
confidential information
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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 ...
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.
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
Aug 1, 2016 - 15 June 2016, 11:00hrs to 16:30hrs â meeting room: 3E ... hosting a workshop that represents the culmination of the consultation process that ...
