EU Regulatory Network To form a critical view on the current and - PDF document

EMEA-CHMP Think-Tank group on Innovation EU Regulatory Network To form a critical view on the current and future scientific development of medicinal products and related regulatory standards in Europe: Challenges and Opportunities for Croatia � To identify bottlenecks in the development of medicinal products Rijeka, November 2008 � To identify possible redundant or irrelevant regulatory requirements EMEA/CHMP- EMEA/CHMP -Think Tank Group on Innovation, Research Think Tank Group on Innovation, Research � To discuss the application of new methods and procedures in and Drug Development and Drug Development the development and regulation of medicinal products � To support European Commission in Innovative Medicines Xavier Luria, MD Initiative Head of Safety and Efficacy of Medicines, H- Pre Unit � To facilitate discussions between CHMP, academia and EMEA industry on innovative approaches for the development of medicinal products EMEA-CHMP Think-Tank group on Innovation Participants of the EMEA-CHMP Think-Tank group • Meetings with 14 pharmaceutical companies • Daniel Brasseur, Chair • Bo Aronsson 11/2005-2006 • Gonzalo Calvo Rojas • Emer Cooke • Bruno Flamion, Vice Chair • Xavier Kurz • Bengt Danielsson • Patrick Le Courtois • Meetings with academic groups 4Q/2006: • Robert Hemmings • Xavier Luria – EASD (European Association for the Study of Diabetes) • Pekka Kurki • Outi Maki-Ikola, Project EFNS (European Federation of Neurological Societies) Manager • Ingemar Persson • Marisa Papaluca-Amati – EORTC (European Organisation for Research and • Patrick Salmon • John Purves Treatment of Cancer) • Cristina Sampaio • Agnes Saint-Raymond – ESCMID (European Society for Clinical Microbiplogy and infectious Diseases) • Spiros Vamvakas • Final Report: March 2007 http://www.emea.europa.eu/pdfs/human/itf/12731807en.pdf EMEA-CHMP Think-Tank group on Innovation EMEA-CHMP Think-Tank group on Innovation • Areas for improvement in the EMEA/CHMP operations – Communication during the lifecycle of the product 1. Communication and interaction with regulators – Guidelines during the lifecycle of the products • Scientific topics 2. Global harmonisation – Biomarkers – Statistical methods and clinical study designs 3. Emerging science for clinical development and – Faster access tools regulatory approval – Risk Management Plans 3.a Translational development, clinical • Areas for the attention of the EC and NCAs in the EU methodology Network 3.b Advanced Therapies – Guidelines for Clinical trials – Global aspects 4. Pharmacovigilance – Interaction between Industry and Academia 5. Guidelines – Advanced Therapies • Special public health topic: Antimicrobial resistance 6. Antimicrobials

Think- -tank tank’ ’s: recommendations for action s: recommendations for action Think- -tank tank’ ’s: recommendations for action s: recommendations for action Think Think Which approach has been taken for implementation Which approach has been taken for implementation Which approach has been followed for implementation Which approach has been followed for implementation Actions undertaken within the frame of the EMEA improvement Actions undertaken within the frame of the EMEA improvement 1. Interactions with stakeholders: in depth and well prepared exercise for operations in the area of exercise for operations in the area of Human medicines Human medicines discussion meetings 2005-2006 � � «signals» for action � � undertaken immediately by the EMEA – Improved procedures – Improved procedures • OMP: better use of resources • OMP: better use of resources 2. Think-tank Report published March 2007 • SA: implementation pre SA: implementation pre- -submission, shorter timelines submission, shorter timelines • and extended involvement of expertise via IT methods and extended involvement of expertise via IT methods 3. Plan for implementation agreed by the CHMP Dec 07 • Pharmacovigilance referrals: streamline of procedures • Pharmacovigilance referrals: streamline of procedures and better information to the public and better information to the public • • Plasma master files: better information Plasma master files: better information 4. EMEA Executive launches an EMEA-wide process improvement • • Pharmacovigilance: improvement in signal detection Pharmacovigilance: improvement in signal detection project (ongoing) – Improved CHMP and working parties meetings management Improved CHMP and working parties meetings management – 5. CHMP work programme 2008-2010 Think- Think -tank tank’ ’s: recommendations for action s: recommendations for action Think- Think -tank tank’ ’s: recommendations for action s: recommendations for action Areas for action agreed with the CHMP (1) Areas for action agreed with the CHMP (1) Areas for action agreed by the CHMP (2) Areas for action agreed by the CHMP (2) 4. 4. Emerging science for clinical development and regulatory approval Emerging science for clinical development and regulatory approva l 1. Areas for action 1. Areas for action with with general general impact impact • Support to early clinical development, translational medicine • Support to early clinical development, translational medicine IMI, interaction with IMI, interaction with networks, modernisation of networks, modernisation of working working and and • • Innovative R&D methods including biomarkers, new imaging Innovative R&D methods including biomarkers, new imaging communication methods communication methods techniques, modelling and simulation, new statistical techniques, modelling and simulation, new statistical approaches approaches 2. 2. Communication and interaction during the lifecycle of the produ Communication and interaction during the lifecycle of the products cts • • F Faster access tools: conditional approval and accelerated aster access tools: conditional approval and accelerated review review Early dialogue on innovation, scientific advice, gap between SA Early dialogue on innovation, scientific advice, gap between SA • Advanced therapies • Advanced therapies and MAA and MAA 3. 3. Global harmonisation Global harmonisation 5. 5. Pharmacovigilance Pharmacovigilance ICH, Bilateral arrangements ICH, Bilateral arrangements 6. 6. Guidelines Guidelines 7. 7. Antimicrobials Antimicrobials Think- Think -tank tank’ ’s: recommendations for action s: recommendations for action Think Think- -tank tank’ ’s: recommendations for action s: recommendations for action 1. Innovative Medicines Initiative 1. Interaction with networks 1. Innovative Medicines Initiative 1. Interaction with networks � ENCePP network : phase 1 of the project completed. Five ENCePP EMEA Policy on the participation in Innovative Medicines Initiative EMEA Policy on the participation in Innovative Medicines Initiat ive working groups active. Representatives of learned societies members (IMI) – (IMI) – research projects published May 2008) research projects published May 2008) of the ENCePP Advisory Board http://www.emea.europa.eu/pdfs/24929308en.doc http://www.emea.europa.eu/pdfs/24929308en.doc In response to this paper 10 consortia requested EMEA to participate � Paediatric network: implementation strategy published Jan 08; to foster high quality ethical research on medicinal products to be used Advisory body for decisions established (SMO) Advisory body for decisions established (SMO) in children, strengthening scientific, technical and/or administrative competences in the performance of paediatric clinical EMEA partner of a consortium EMEA partner of a consortium trials � � Coordination group to start in 2009 � � EMEA leading an applicant consortium to address the call for EMEA leading an applicant consortium to address the call for “Strengthening the monitoring of Benefit “ Strengthening the monitoring of Benefit- -Risk Risk” ” � New process for Learned societies and stakeholders active consultation on EMEA scientific work: database and procedures being Making partnership to happen and establishing the grounds for Making partnership to happen and establishing the grounds for established (MIS) � � � � 2009 transparent and fair future involvement: requests for participation to transparent and fair future involvement: requests for participat ion to consortia have now their pathway. consortia have now their pathway. � Activities of the HCP and PO working group: reinforced contribution to EMEA activities in 2009