12 September 2017 EMA/406983/2017 Procedure Management Department
Agenda – Industry and assessors’ joint training on how to improve the content of periodic safety update reports 22 September 2017, 9:00-11:00, Meeting room 3E
Chair: Menno van der Elst Objective of the training: identifying key issues encountered by Industry and Regulators in the preparation of PSURS, sharing Best Practice (advice) on ways to address these key issues to achieve a common understanding of the quality standards needed to facilitate the EU PSUR single assessment. High PSUR quality is essential to support the overall safety evaluation and integrated critical benefitrisk evaluation in the context of the life cycle of medicinal products and is therefore key in supporting public health.
Item
Agenda
1.
Welcome
Initials
Mins
ME
5
Introduction to PSUR roadmap: explanatory note to GVP VII and Q&A for assessors
2.
Purpose of the training: how to improve the content of PSURs
Signals and close monitoring in the PSUR
60
1.a) Preparing for a signal presentation / evaluation (industry’s
CH
perspective) Background + practical examples + solution 1.b) How to address requests for close monitoring (industry’s
VS
perspective) Background + practical examples + solution 2. What do assessors expect to receive in a PSUR? (regulatory
UW
authorities’ perspective) Background + practical examples + solution 3. Q & A (all) 4. Summary of common understanding (industry/network) Bullet points prepared in advanced in line with the papers agreed with
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
Safety specifications 1. How is the inclusion of safety concerns substantiated (industry’s
Initials
Mins 20
KMB
perspective) Background + practical examples + solution 2. Request to review the safety specification (regulatory authorities’
ME
perspective) Background + practical examples + solution 3. Q & A (all) 4. Summary of common understanding (industry/network) Bullet points prepared in advanced in line with the papers agreed with 4.
Product information / Reference safety information 1. QPPV oversight of the product information (industry’s perspective)
20 MR
Background + practical examples + solution 2. The role of the RSI and/or the PI (regulatory authorities’
ME
perspective) Background + practical examples + solution 3. Q & A (all) 4. Summary of common understanding (industry/network) Bullet points prepared in advanced in line with the papers agreed with 5.
Use of summary tabulations 1. How are they created (industry’s perspective)
10 DL
Background + practical examples + solution 2. Place in the assessment of PSURs (regulatory authorities’
ME
perspective) Background + practical examples + solution 3. Q & A (all) 4. Summary of common understanding (industry/network) Bullet points prepared in advanced in line with the papers agreed with 6.
Close of training/Next steps
ME
5
List of speakers’ acronyms: Menno van der Elst (ME) Craig Hartford (CH) Valerie Simmons (VS) Ulla Wändel (UW) Klaudija Marijanovic Barac (KMB) David Lewis (DL) Michael Richardson (MR) Kora Doorduyn-van der Stoep (KDS)
Agenda – Industry and assessors’ joint training on how to improve the content of periodic safety update reports EMA/406983/2017
Agenda joint training - European Medicines Agency - Europa EU
6 days ago - Send a question via our website www.ema.europa.eu/contact ... preparation of PSURS, sharing Best Practice (advice) on ways to address these key issues to ... 1.b) How to address requests for close monitoring (industry's.
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
