Work plan for the Radiopharmaceutical Drafting Group for 2017
Chairperson: Anabel Cortes Blanco Status of the work plan: Adopted in December 2016
1. Meetings scheduled for 2017 Face-to-face meetings are planned for the following dates:
18 September 2017
Virtual meetings are planned for the following dates:
20 January 2017
26 April 2017
19 May 2017
27 July 2017
16 November 2017
Virtual meetings/web sharing will be planned to accommodate scientific input to products scientific advice and evaluation. Additional teleconferences will be organised ad-hoc to respond to time-sensitive input on products and to progress guidelines, as required.
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
Core SmPC and PL for technetium (99mTc) HDP and (99mTc) MDP Target date
Q1 2017
Comments
New guideline for external consultation
Core SmPC and package leaflet for technetium (99mTc) medronate Target date
Q1 2017
Comments
New guideline for external consultation
Core SmPC and package leaflet for technetium (99mTc) macrosalb Target date
Q1 2017
Comments
New guideline for external consultation
Core SmPC and package leaflet for iobenguane (123I) Target date
Q2 2017
Comments
New guideline for external consultation
Core SmPC and package leaflet for sodium iodide (131I) therapy capsules Target date
Q2 2017
Comments
New guideline under external consultation
Core SmPC and package leaflet for iopamidol 300/370 mg I/ml Target date
Q2 2017
Comments
New guideline for external consultation
Core SmPC and package leaflet for technetium (99mTc) exametazime Target date
Q2 2017
Comments
New guideline for external consultation
Core SmPC and PIL of lutetium (177Lu) chloride Target date
Q2 2017
Comments
New guideline for external consultation
Core SmPC and PIL of fluorocholine (18F) Target date
Q2 2017
Work plan for the Radiopharmaceutical Drafting Group for 2017 EMA/CHMP/633868/2016
Page 2/4
Comments
New guideline for external consultation
Core SmPC and package leaflet for gadopentetate dimeglumine Target date
Q4 2017
Comments
New guideline under review following external consultation
Core SmPC and package leaflet for (68Ge/68Ga) generator Target date
Q4 2017
Comments
New guideline under review following external consultation
Core SmPC and package leaflet for fluorodopa (18F) Target date Comments
Q4 2017 New guideline under review following external consultation
Core SmPC and package leaflet for gadoteric acid Target date Comments
Q4 2017 New guideline under review following external consultation
Action: Specialised input Draft annex for harmonisation of wording on safety information in the core SmPC/PL of iodinated contrast agents. Target date
2Q 2017
Comments
In consultation with the SmPC advisory group, the RadDG will prepare an annex to harmonise class-related safety information aspects for core SmPCs of iodinated contrast agents. This annex will be released with the core SmPC and PL for iopamidol 300.
Draft annex for harmonisation of wording on safety information in the core SmPC/PL of Gadoliniumbased contrast agents. Target date
2Q 2017
Comments
In consultation with the SmPC advisory group, the RadDG will prepare an annex to the SmPC for Gadolinium-based contrast agents to harmonise class-related safety information aspects for core SmPCs of Gadolinium-based contrast agents.
2.2. EU Guidelines under revision Action: Lead Core SmPC and Package Leaflet for Radiopharmaceuticals, EMA/CHMP/167834/2011
Work plan for the Radiopharmaceutical Drafting Group for 2017 EMA/CHMP/633868/2016
RadDG Work plan 2017 - European Medicines Agency - Europa EU
Dec 15, 2016 - Work plan for the Radiopharmaceutical Drafting Group for. 2017. Chairperson: Anabel Cortes Blanco. Status of the work plan: Adopted in ...
Jan 26, 2017 - different aspects, or if these aspects call for the development of new ... Joint EMA Symposium in the margins of the CEN-ISBS conference, ...
Feb 15, 2017 - Improve the quality of initial orphan designation applications by ... Maintenance ... Development of strategies to implement recommendations ...
Apr 12, 2017 - Member. Marc Turner. Scottish National Blood Transfusion. Service .... CAT will collaborate with the BWP and the HMA innovation network on this ... 1.3.3. Addressing the Environmental Risk assessment of ATMPs containing.
Jan 27, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 .... best available scientific expertise in the Network and ensure that paediatric information related
5 days ago - Guidelines should include more details on the principles of good information design in which content and layout are ... relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool .... databas
Jan 31, 2018 - Activities in 2018. PRAC activities to achieve the objectives set for this area: â¢. Review of lessons learnt from the pilot regulatory network study involving EMA, Spain and the United Kingdom, as a source of learnings for regulatory
Dec 14, 2017 - Send a question via our website www.ema.europa.eu/contact ... ad-hoc to respond to time-sensitive requests on products and to progress guidelines, as required. 2. Guidelines. 2.1. New EU Guidelines ... Recommendation to the CAT on data
Jul 5, 2017 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
May 8, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Jan 30, 2018 - HMPC work plan. EMA/HMPC/150152/2018. Page 2/7. Evaluation activities for herbal medicinal products as defined in Reg. (EC) No 726/2004 and Dir. 2001/83/EC. 1.1. Establishment and update of EU herbal monographs and list entries. Activi
Feb 13, 2017 - Monthly report on application procedures, guidelines and .... of MRLs for new substances under article 3 of Regulation (EC) No 470/2009.
Oct 9, 2017 - In 2017, an audit of the EU Portal and Database will take place and, on the basis of .... These frameworks collectively offer a platform for exchange and multi-stakeholder dialogue at the. European ...... EudraVigilance database and by
Oct 13, 2017 - applications for initial evaluations, extensions, variations and renewals concerning marketing authorisations (MAs); ... Initial evaluation of marketing authorisation applications. 2014. 2015. 2016 .... Out of scope. 1 Establishment of
Mar 16, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Oct 9, 2017 - possible expertise for the regulation of medicines in the European Union (EU). To deliver on its responsibilities, EMA works closely with the NCAs. This means the environment, trends, workload forecasts and implementation of a number of
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 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Feb 9, 2017 - Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply).
Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
