20 September 2016 EMA/428004/2016 Stakeholders and Communication Division

Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting 20 September 2016, 08:30hrs to 16:30hrs – meeting room: 2A

Chair: Isabelle Moulon (EMA) 20 September 2016 08:30

Action

Speaker

Registration and reimbursement arrangements (HCPWP)

1. Election of HCPWP co-chair (HCPWP members only) 08:45

Welcome and introduction / Health and safety information

I. Moulon (EMA)

Disclosure of interests / Adoption of the agenda 08:50

1.1 HCPWP co-chair election proceedings

Election

I. Silva / A. Spina (EMA)

1.2 Nomination of observers to the PCWP 09:30

1.3 EMA revised framework of interaction with

For agreement

I. Silva (EMA)

healthcare professionals After the election is finalised HCPWP members leave the room to return at 11h15 10:00

Registration and reimbursement arrangements (PCWP)

2. Election of PCWP co-chair (PCWP members only) 10:15

Welcome and introduction / Health and safety information

I. Moulon (EMA)

Disclosure of interests / Adoption of the agenda 10:20

2.1 PCWP co-chair election proceedings 2.2 Nomination of observers to the HCPWP

11:00

Election

N. Bere / A. Spina (EMA)

Coffee Break

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

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

20 September 2016

Action

Speaker

For

M. Papaluca (EMA)

3. Personalised medicine 11:15

3.1 Recent developments

information 11:35

3.2 Forward together: EAPM achievements and initiative (2016-17)

12:00

3.3 What are the areas of interest and concern

For

D. Horgan (EAPM)

information For discussion

Open discussion

For

PCWP/HCPWP

information/

Committee members

for patients and healthcare professionals 12:45

Lunch

4. Committee feedback 13:30

4.1 Feedback from scientific committees

discussion 5. Members voice: sharing practices 14:00

5.1 Health Literacy, Young Patients with Asthma and Adherence to Treatment

14:20

5.2 State of Health in the EU: the Community Pharmacy Contribution

14:30

For

E. Botjes (EFA)

information For

J. Wilkinson (PGEU)

information

Coffee break

6. Working party organisational matters 14:45

6.1 Progress report from PCWP and HCPWP topics groups

For

PCWP/HCPWP co-

information/

leads

discussion 15:15

6.2 PCWP and HCPWP work programmes for

For agreement

2017 15:45

6.3 EMA framework of collaboration with academia

7. AOB 16:30

End of meeting

N. Bere/ I. Silva (EMA)

For information

M. Ensini (EMA)

Agenda - European Medicines Agency - Europa EU

Sep 20, 2016 - I. Moulon (EMA). 08:50. 1.1 HCPWP co-chair election proceedings. 1.2 Nomination of observers to the PCWP. Election. I. Silva / A. Spina. (EMA).

187KB Sizes 0 Downloads 106 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