Work plan for the Respiratory Drafting Group (RDG) for 2018
Chairperson: Karolina Törneke Status of the work plan: December 2017 – Adopted 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.
1. Meetings scheduled for 2018 Face-to-face meetings are planned for the following dates: •
22-23 March 2018
•
18-19 October 2018
The above mentioned dates may be modified as needed. Additional virtual meetings may be organised ad-hoc to respond to time-sensitive requests on products and to progress guidelines, as required.
2. Guidelines 2.1. EU Guidelines under revision Action: Lead Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis (CHMP/EWP/9147/08) Target date
Draft guideline to be released for 6 month public consultation Q2-Q3 2018
Comments
Revision to bring the guideline in line with the current clinical knowledge and developments.
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
Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1) Target date
Draft guideline to be released for 6 month public consultation Q3 2018
Comments
Consultation of other Working Parties (e.g. Quality Working Party, Pharmacokinetics Working Party) and PDCO
Action: Lead Concept paper on acute respiratory distress disease Target date
Draft concept paper to be released for 6 month public consultation Q1-Q2 2019
Comments
New guideline to develop in line with current scientific knowledge and recent scientific advices
2.2. ICH Guidelines None
3. Medicinal Products-specific activities 3.1. Pre-Authorisation activities Support to Scientific Advice and Protocol Assistance in the field of respiratory diseases upon request
3.2. Evaluation and supervision activities Contribution to product assessment and post-authorisation issues in the field of respiratory diseases upon request
4. Input in European activities 4.1. Training for the network and knowledge building None
5. Input in International activities (beyond ICH guidelines) None
Work plan for the Respiratory Drafting Group (RDG) for 2018 EMA/CHMP/383892/2017
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6. Contribution to dialogue and engagement with stakeholders and external parties None
In addition to the actions identified above, the working party can be involved in any other activities foreseen in its mandate: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/08/WC500095453.pdf
Work plan for the Respiratory Drafting Group (RDG) for 2018 EMA/CHMP/383892/2017
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
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
Dec 15, 2016 - Work plan for the Radiopharmaceutical Drafting Group for. 2017. Chairperson: Anabel Cortes Blanco. Status of the work plan: Adopted in ...
Jan 25, 2017 - Also in June 2016, EMA's multiannual work programme to 2020 was published, .... of the workshops organised in 2016 on social media, mHealth/apps (IMI- ... Follow the outcome of the social media workshop held in 2016, ...
Jan 25, 2017 - In June 2016 the PCWP started its new mandate for the period .... Follow the outcome of the workshops organised in 2016 on social media, mHealth/apps (IMI- ... Follow the outcome of the social media workshop held in 2016, ...
Dec 8, 2016 - Application of the 3Rs in Regulatory Testing of Medicinal Products (3R's) .................. 9 ... intended to stimulate development of new veterinary medicines for minor species and/or for rare diseases in .... throughout their lifecyc
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
EMA/CVMP/SWP/278493/2017. Committee for Medicinal Products for Veterinary Use (CVMP). Work plan for the CVMP Safety Working Party (SWP-V). 2018. Chairpersons. Status. Chair: E. Lander Persson. Vice-chair: S. Scheid. Adopted by CVMP in December 2017.
Key information for patients, consumers and healthcare professionals. Published monthly by the European Medicines Agency. An agency of the European Union. HUMAN MEDICINES. HIGHLIGHTS. Issue 107. February 2018. This newsletter is addressed primarily t
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
Jun 23, 2017 - 6.1.2. Business process changes and resourcing requirements . ..... It is suggested that all impacted organisations should prepare plans ..... formats and the interface has been updated to the new software ... nullified if the pre-exis
Jan 31, 2017 - E-mail [email protected] Website www.ema.europa.eu ... 1) For new initial marketing authorisation (MA) applications via the centralised ...
Jan 31, 2017 - E-mail [email protected] Website www.ema.europa.eu ... 1) For new initial marketing authorisation (MA) applications via the centralised ...
Jun 8, 2018 - (NCAs), EMA and marketing authorisation holders (MAHs) for effective ... and engagement are covered to ensure that a platform for learning, ...
Jun 23, 2017 - 5.2.3. EudraVigilance database management system (EVDBMS) . ...... In addition, the Agency will also change the way organisations and ... through a call for volunteers via the EudraVigilance Expert Working Group and the.
Mar 15, 2018 - (Article 5(12) (b) of Regulation (EC) No 141/2000 of the European Parliament and of the Council). When a designated orphan medicinal product receives a positive opinion for marketing authorisation from EMA's Committee for Medicinal Pro
Jul 12, 2018 - An agency of the European Union ... This list only includes information for medicines whose applications have been validated at the time the.
Jun 22, 2018 - An agency of the European Union. Telephone +44 (0)20 ... Selumetinib for treatment of neurofibromatosis type 1, AstraZeneca AB;. â¢. Synthetic ...
