14 March 2018 EMA/775204/2017 Stakeholders and Communication Division
DRAFT Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting 17 April 2018, 08:30hrs to 17:30hrs – 18 April 2018, 08:30hrs to 16:30hrs meeting room: 3A
Co-Chairs: Juan Garcia-Burgos (EMA), Kaisa Immonen (PCWP), Gonzalo Calvo (HCPWP) 17 April 2018
Action
08:30
Registration and reimbursement arrangements
08:45
Welcome and introduction / Health and safety information
Speaker
J. Garcia-Burgos (EMA)
Disclosure of interests / Adoption of the agenda 1. Digital media and health 09:00
1.1 Perspectives from the European
For information
K. Neubauer (EC)
Commission 2. Real world evidence – what have we learnt lately at EMA? 09:30
H-G. Eichler (EMA)
2.1 An introduction to the concept and how is it relevant for the medicines regulatory system
10:00
2.2 Learnings from a series of workshops
For information
A. Cave (EMA)
10:25
2.3 How are real-world evidence and patient
For information
J. Moseley (EMA)
For discussion
D. Singer (HCPWP)/
registries used in benefit-risk evaluation to support early access to medicines 10:50
Coffee Break
11:10
•
Discussion points −
Identify points of concern/reflection
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimil +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Reflect on how to address identified concerns and best communicate to patients and healthcare professionals in a clear and comprehensible manner.
3. Electronic product information 12:00
3.1 Towards electronic product information in the EU
12:20
3.2 Mapping EU initiatives on electronic
Support for better use of
product information
medicines) 13:15
Lunch
4. mHealth – recent learnings and trends 14:00
4.1 Findings from the WebRADR project
For information
V. Newbould (EMA)
14:30
4.2 Trends in marketing authorisation
For information
F. Cerreta/ A. Skarlatos (EMA)
applications 15:15
•
Discussion points −
For discussion
K. Apostolidis (PCWP)
For information
M. Benstetter/
Identify points of concern/reflection from patients and healthcare professionals;
−
Reflect on the need for a guideline for patients on how to assess open mHealth apps solutions.
16:00
Coffee break
5. Social media – focusing on increased outreach 16:15
5.1 EMA’s approach to social media
C. Enachioiu (EMA) 16:45
5.2 Outreach to targeted audiences
17:30
End of day
For discussion
C. Morton (PCWP)
DRAFT Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting EMA/775204/2017
Page 2/4
18 April 2018 08:30
Action
Introduction to Day 2 and review of: •
Actions from previous meetings
•
Draft proposals open for consultation
•
Outcome of written procedures
Speaker J. Garcia-Burgos (EMA)
6. EMA relocation 09:00
6.1 Update on business continuity
For information
N. Wathion (EMA) (TBC)
09:20
6.2 Stakeholder communication and
For discussion
MA. Heine/ M. Benstetter (EMA)
engagement throughout the relocation phase 7. European Immunisation Week 09:40
7.1 Update on EMA communication activities
10:00
Coffee Break
For information
M. Benstetter (EMA)
For information
AS. Henry-Eude/ M. Dias
8. Transparency and clinical trials 10:20
8.1 Clinical data publication policy –
(EMA)
experience since Oct 2016 and Technical Anonymization Group 11:00
8.2 Implementation of Clinical Trial Regulation
For information
A. Rodriguez (EMA)
For discussion
J. Januskiene (EMA)
For information
AC. Schmidt (EMA)
For discussion
Y. Knudsen (NOMA) /
– update on EU-CT portal and database 9. Pharmacovigilance 11:35
9.1 Findings of the EMA survey on awareness of the ‘additional monitoring’ concept and next steps
10. EMA corporate website 12:15
10.1 Relaunch of EMA corporate website
12:30
Lunch
11. Access to medicines 13:15
11.1 EMA-HMA collaboration on shortages and
Additional speaker TBC
availability of medicines: stakeholder input for the November 2018 workshop 14:15
11.2 EMA-EUnetHTA collaboration: mutual learning concerning practices for
For discussion
A. Willemsen / C. Guilhaume (EUnetHTA)
engagement with patients and healthcare professionals in assessment activities
DRAFT Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting EMA/775204/2017
Page 3/4
18 April 2018 15:00
Action
Speaker
Coffee break
12. Committee feedback 15:15
12.1 CHMP 12.2 COMP 12.3 CAT 12.4 HMPC
For information
12.5 PRAC 12.6 PDCO 13. Members voice 16:00
13.1 Online training for MS nurses project, MS
For information
A. Antonovici (EMSP)
Nurse Professional 14. AOB 16:30
End of meeting
DRAFT Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting EMA/775204/2017
EMA Human Scientific Committees' Working Parties with Patients' and ...
Apr 17, 2018 - 10:25 2.3 How are real-world evidence and patient registries used in benefit-risk evaluation to support early access to medicines. For information J. Moseley (EMA). 10:50 Coffee Break. 11:10 â¢. Discussion points. â Identify points of concern/reflection. For discussion. D. Singer (HCPWP)/. K. Breen (PCWP) ...
Jun 14, 2017 - Send a question via our website www.ema.europa.eu/contact ... With this in mind DG SANTE strongly recommended that, centralised regulatory ... building on existing knowledge, or through knowledge transfer whilst assuring ...
authorisation application to EMA. Each new medicine is ... EMA encourages research and development of new ... in the EU, we have access to the best scientific.
EMA provides training and support to ensure the voice of patients and healthcare professionals is heard all along the regulatory lifecycle of medicines. 23. 25. 25.
Dec 20, 2015 - for Social Research, Helsinki Center of Economic Research, CERGE-EI Prague, the 2014 Trento ... to observe a list of prospective candidates.
May 8, 2016 - particularly relevant when there exists a large degree of uncertainty .... To foster public scrutiny, the evaluation agency publishes online the CVs ...
... with Enpr-EMA when planning. Paediatric Development in the EU. 2. Draft an advertisement to publicise the guidance, circulate it to industry and Enpr-EMA for.
Product Development and Scientific Support Department .... context of the harmonisation of the application process, that will be implemented with the Clinical.
Beyond these, there are dozens of additional good guides. (For a small sampling, see ...... to review the complete documentation at (http://cran.r-project.org/web/.
www.census.gov/developers/tos/key_request.html and fill out the simple ... function returns a new geo.set object holding this information.2 If you assign.
ter oral administration of FC (50 mg/kg BW), and after oral administration of FT (25 ..... E.coli (in 72,14% of the patients), E. faecalis (10,70%), S. sap- rophyticus ...
STAFF. Robert Kunkle, M.A., Senior Program Manager. Amy B. Albert, B.A., Assistant Project Manager. Laura J. Fochtmann, M.D., Medical Editor ...... Braun P, Greenberg D, Dasberg H, Lerer B: Core symptoms of posttraumatic stress disorder unimproved by
Peter Rock, MD, MBA, FCCP, FCCM. Department of ..... airway surgery in patients with OSA, little information exists on which to base decisions regarding the ...
are found the prognosis of operation is less favorable (Lee et al., 2005). In 15 out of 20 patients with a neocortical tem- poral lobe epilepsy without abnormalities ...
dial ischemia and reinfarction over the same interval, and for this benefit 13-blockade is recommended in association with thrombolytic therapy. Total mortal-.
METHODS. The charts of all patients with ankylosing spondylitis who presented between 1996 and 2000 for medical rehabilitation ... The software program Sig-.
Jun 15, 2017 - training tools and materials and developing new ones ..... which is responsible for the assessment and monitoring of human ...... Alert Card).
for which more research data are needed to guide clinical decisions. ..... the therapeutic alliance; the presence of psychosocial or environmental difficulties; the ...
Correspondence should be addressed to Nicolas Bruno, Service de Psychiatrie, HÑpital Saint. Antoine .... Patients were recruited from the outpatient services of the university hospital Le ..... A comparison of clustering solutions for cognitive ...
