8 February 2018 EMA/PDCO/566046/2017 Inspections, Human Medicines Pharmacovigilance and Committees Division
PDCO work plan 2018 adopted by the Committee on 15 December 2018
Table of Content 1. Evaluation activities for human medicines .............................................. 2 1.1. Facilitate patients access to medicinal products specifically authorised for children ....... 2 1.2. Development of Therapeutic Areas strategies ........................................................... 2 1.3. Other specialised areas and activities ...................................................................... 2 1.3.1. Neonatology group ............................................................................................ 2 1.3.2. Modelling and Simulation .................................................................................... 3
2. Horizontal activities and other areas ....................................................... 3 2.1. Committees and Working parties ............................................................................ 3 2.1.1. Collaboration with PRAC ..................................................................................... 3 2.1.2. Non-clinical working group .................................................................................. 4 2.1.3. Formulation working group ................................................................................. 4 2.2. Partners and stakeholders ..................................................................................... 4 2.2.1. Strengthen dialogue with all stakeholders ............................................................. 4
The activities outlined in the work plan for 2018 have been agreed considering the respective business priorities, as well as the Agency’s relocation as a result of the UK’s exit from the EU and its impact on the Agency’s business continuity, and may be subject to further review and reprioritisation in accordance with the business continuity plan of the Agency.
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
1. Evaluation activities for human medicines 1.1. Facilitate patients access to medicinal products specifically authorised for children Key objective The PDCO will foster optimal cooperation with the European Commission to ensure the development of an action plan and its implementation based on the conclusions from the EC 10-year report on Paediatric Regulation.
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
PDCO contribution to prepare the EC/EMA action plan based on the conclusions from the EC 10year report on Paediatric Regulation.
PDCO topic leader: Dirk Mentzer •
Contribution to a multi-stakeholder workshop to finalise the action plan in Q1/2018
PDCO topic leader: Dirk Mentzer •
Review of the criteria to determine paediatric therapeutic needs, and initiate a pilot in identified therapeutic areas.
PDCO topic leader: Karl-Heinz Huemer
1.2. Development of Therapeutic Areas strategies Key objectives Define strategies on how to approach PIPs for identified therapeutic areas.
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
Review of the experience acquired by the PDCO in evaluating PIPs in 2 therapeutic areas or conditions (to be determined based on paediatric medical need and/or difficulties to progress with paediatric developments) in order to identify gaps and potential solutions to address them.
1.3. Other specialised areas and activities 1.3.1. Neonatology group Key objectives
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To actively work with stakeholders in the neonatology field to leverage their experience on questions related to clinical studies of investigational medicinal products for neonates and reflect on the current regulatory guidance, the recent progress in science and the experience acquired by the PDCO in evaluating PIPs involving neonates.
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
Finalise the revision of the EMA neonatal guideline;
•
Continue working in collaboration with the International Neonatal Consortium, in specific areas (e.g. neonatal seizures, bronchopulmonary dysplasia, neonatal pharmacology).
PDCO topic leader: Dina Apele-Freimane
1.3.2. Modelling and Simulation Key objectives Continue to integrate modelling and simulation expertise into the work of the PDCO and ensure that methodological approaches are consistently applied by the PDCO in coordination with the Modelling and Simulation Working Group (MSWG).
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
Update, in collaboration with the MSWG, the required information on Modelling and Simulation in PIP Summary Reports and in the key binding elements in the PIP opinions.
•
Define criteria for MSWG involvement (in reviewing modelling and simulation studies) and translation into a PIP Opinion key binding element measure.
PDCO topic leader: Sylvie Benchetrit
2. Horizontal activities and other areas 2.1. Committees and Working parties 2.1.1. Collaboration with PRAC Key objectives Ensure that the needs of the paediatric population are systematically considered in the medicinal products development and assessment. Reinforce cooperation with other EMA Scientific Committees with a view to supporting the continuity of the paediatric safety and efficacy assessment throughout the lifecycle of medicines.
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
Within the PRAC-PDCO Working Group, discuss the approach when a PIP study becomes a postauthorisation study as part of the RMP.
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PDCO topic leader: Dirk Mentzer
2.1.2. Non-clinical working group Key objectives To contribute to a global non-clinical strategy to support paediatric studies. To evaluate the value of juvenile toxicity studies in the therapeutic areas of neurology and psychiatry.
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
Contribution to relevant International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, such as ICH S11 ‘Nonclinical Safety Testing in Support of Development of Paediatric Medicines’ and ICH S5(R3) ‘Detection of Toxicity to Reproduction for Human Pharmaceuticals’;
•
Finalisation of the review of the significance of juvenile toxicity studies included in PIPs in the therapeutic areas of neurology and psychiatry (i.e. central nervous system active drugs);
PDCO topic leader: Karen Van Malderen
2.1.3. Formulation working group Key objectives To contribute to a revised guideline on excipients to support paediatric formulations.
Activities in 2018 PDCO activities to achieve the objectives set for this area: •
Contribution to the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00).
PDCO topic leaders: Brian Aylward, Ann Marie Kaukonen
2.2. Partners and stakeholders 2.2.1. Strengthen dialogue with all stakeholders Key objectives Strengthen dialogue with external stakeholders (patients, healthcare professionals (HCP), academia, industry).
Activities in 2018 •
In coordination with Patients’ and Consumers’ Working Party (PCWP), to collaborate on the implementation of the EMA Principles on the involvement of young patients/consumers within EMA activities, to facilitate and promote involvement of young patients within PDCO activities as needed.
PDCO topic leader: Helena Fonseca
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•
To increasingly use European network of paediatric research at the EMA (Enpr-EMA) and its working groups as platform for discussion among academia and industry with the PDCO
PDCO topic leaders: Angeliki Siapkara, Marek Migdal
PDCO work plan 2017 - European Medicines Agency - Europa EU
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 to the clinical trial programme is included in the medicine SmPC and ...
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.
Dec 15, 2016 - Work plan for the Radiopharmaceutical Drafting Group for. 2017. Chairperson: Anabel Cortes Blanco. Status of the work plan: Adopted in ...
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).