EU Update on Regulatory Developments
|
|
- Amos Lester
- 6 years ago
- Views:
Transcription
1 EU Update on Regulatory Developments Pascal Venneugues European Medicines Agency CASSS CMC Strategy Forum Europe Copenhagen, 4-6 May 2015 An agency of the European Union
2 Overview International cooperation and globalisation challenges Lifecycle management (ICH Q12) Adaptive pathways and impact on CMC Update on BWP Process Validation Guideline Future directions 1
3 Why cooperate with international partners? Changing environment due to global nature of pharma R&D Movement of clinical trials outside of EU and US Increasing complexity of supply chains and manufacture of APIs outside of the EU increasing risks of falsification and concerns over data integrity Increasing needs for international collaboration, information sharing and work sharing reduce/avoid duplication, global strategic vision 2
4 Where do our active substances come from? Non-EU India & China ROW EU 1/3 of APIs come from EU 2/3 of APIs imported from non-eu countries India and China account for 70-80% of non-eu API supply Primary supplier in ROW is USA Source: EGA (2015) About 70% of inspections requested by EMA and about a third of national inspections take place in the USA but less than half of all EMA/national inspections are carried out in India & China. Mutual Reliance Initiative: Joint EMA-FDA initiative to accept each other s GMP inspections of manufacturing sites Better use of inspection resources 3
5 EU Directive on falsified medicines Medicine with a false representation of: - Identity (name, composition, strength, packaging, labelling) - Source (manufacturer, country of manufacturing, country of origin, MAH) - History (distribution records) Does not include - unintentional quality defects - Infringements of intellectual property rights Four pillars: 1. Safety features 2. Good Distribution Practices 4. Internet sales 3. Active substances 4
6 EU Directive on falsified medicines Ongoing work to implement the Directive Equivalence to EU GMP standards and practices of 3 rd countries exporting active substances to the EU: Written confirmations issued by competent authorities of 3 rd countries (e.g. India, China) Requirement waived for countries included in a list established by the Commission (USA, Japan, Switzerland, Australia) Assessment is ongoing for several countries (e.g. Israel, South Korea, Brazil) Exceptionally, requirement waived to ensure availability of a product, if the manufacturing site was inspected by a EU Member State. Legislation builds on cooperation activities with third countries 5
7 International cooperation (examples) ICMRA (International Coalition of Medicines Regulatory Authorities) Forum of Heads of Medicines Agencies aimed at providing strategic oversight on issues faced globally 19 countries plus EU (DG SANTE and EMA), across regions, and WHO as observer Working groups: governance, mapping, communication, information sharing, GMP inspections, generic medicinal products, capacity and competence building IPRF (International Pharmaceutical Regulators Forum) Discussions on high priority regulatory issues & challenges, regulatory operations to improve efficiency and effectiveness 10 countries plus EU (DG SANTE and EMA), across regions, and WHO as observer Working groups on gene and cell therapy, biosimilars, ICH E6 (GCP) TTIP (Transatlantic Trade and Investment Partnership) EMA supports Commission in several areas, e.g. GMP, biosimilars Tenth round of negotiations in July
8 EMA-FDA interactions interactions every month through confidentiality arrangements Many activities structured around thematic clusters: Orphan medicines, paediatric medicines, vaccines, oncology, blood products, biosimilars, ATMPs, pharmacovigilance, pharmacogenomics, veterinary medicines Interactions in other areas such as Quality by Design, shortages, antimicrobial resistance (TATFAR) EMA/FDA Parallel scientific advice Many of these interactions also involve Japan, Canada, Australia 7
9 Lifecycle management ICH Q12 Scope: framework to facilitate management of post-approval CMC changes in a more predictable and efficient manner Allow regulators to better understand and have more confidence and trust in the applicant s management of CMC changes Importance of transparency Key topics: Regulatory dossier: communication of information in the CTD (format, location), regulatory commitments PQS: change management, knowledge management Post-Approval Change Management Protocols (PACMPs) EWG face-to-face meeting on 6-11 June 2015 (Fukuoka, Japan) Proposal for BWP/QWP Workshop with Industry (27-28 October 2015) 8
10 ICH Q12 Information in the dossier, regulatory commitments Nowadays marketing authorisation applications include more development information and elements of enhanced approach How to effectively communicate important / relevant aspects of the development program in a submission? Summary of the story in the Quality Overall Summary with links to Module 3 The level of detail is not one size fits all ; it should consider the purpose / use of the studies Terminology matters: avoid terminology contradicting ICH principles Example of issue for biological products: non-cpps - Information in the dossier: which ones, ranges? - Reporting of post-authorisation changes 9
11 ICH Q12 Knowledge management Information in ICH Q10 is high level How to manage knowledge within a company? How to find a format to connect knowledge gain vs change being considered? How to communicate knowledge with regulators Is knowledge inspectable? Clear link with Annual Product Review: what has happened and what has been learnt 10
12 ICH Q12 Post-Approval Change Management Protocols The use of PACMPs relies on the scientific knowledge and understanding that a company has gained about a product and process Prediction of the impact of complex change(s) on product quality Benefits of using PACMPs: Faster and more predictable implementation of post-approval changes continuity of supply Input from regulators on the strategy before submitting the actual results Repetitive implementation of a specific change under a single PACMP More flexible and risk-based approach for managing changes post-approval Different regulatory frameworks between ICH regions 11
13 Adaptive pathways and impact on CMC Requires a well thought out plan in the marketing authorisation application to generate data post-approval. For example: Process validation: concurrent validation protocol New manufacturing site, scale up: opportunity to use PACMPs Specifications: review based on pre-defined criteria, reassessment of control strategy, submission of post-approval variations Shelf life: use of stability models, extrapolation,? Post-approval variation to extend shelf life Use of prior/platform knowledge to guide development An important CMC issue is limited data vs risk management Importance of Scientific Advice (including also EMA-HTA parallel advice) 12
14 Update on BWP Process Validation guideline Public consultation ended on 31/10/2014. Review of comments is ongoing Scope: - What to file in the dossier, not how to validate - Control strategy will not be addressed Distinction between process evaluation and verification is an important concept for biologicals and will be maintained Need to clarify where process development ends and where process evaluation starts 13
15 Update on BWP Process Validation guideline Differences in terminology with FDA guidance are acknowledged Terminology is aligned with existing EU guidance But no differences in concepts with FDA guidance Limited experience on continuous process verification for biologics No detailed guidance will be provided In the context of adaptive pathways, high level guidance on concurrent validation will be introduced Regulatory binding nature of information included in the dossier (e.g. S.2.2 and S.2.4 vs S.2.5 and S.2.6): Issue beyond the PV guideline. To be addressed in ICH Q12 14
16 Future directions Changing face of our international collaboration with regulators From information sharing to work sharing From bilateral to multilateral cooperation Key question is now how best to collaborate Need for continued dialogue and learning by both industry and regulators Support to global development Benefit to the patient Strong regulatory science is critical to innovation Supporting new approaches to improve product manufacturing and quality Ensuring regulators readiness to evaluate innovative emerging technologies EU Medicines Agencies network strategy to 2020: 15
17 Thank you Pascal Venneugues Quality of Medicines Human Medicines Evaluation Division 30 Churchill Place, Canary Wharf, London E14 5EU 16
EMA and international cooperation
EMA and international cooperation The EU medicines regulatory system and the European Medicines Agency: an introduction for international regulators and non-governmental organisations London, 18-19 September
More informationFive years as EMA Liaison at US FDA
Five years as EMA Liaison at US FDA TOPRA Annual Human Medicines Symposium 2 4 October 2017 - Victoria Park Plaza Hotel, London Presented by Dr Sabine Haubenreisser on 2 October 2017 European Medicines
More informationEU Update on Regulatory Developments
EU Update on Regulatory Developments Pascal Venneugues European Medicines Agency CASSS CMC Strategy Forum Europe Killarney, 22-24 May 2017 An agency of the European Union Overview International collaboration
More informationEMA / FDA efforts towards Regulatory Harmonisation - Transatlantic Trade and Investment Partnership (TTIP)
EMA / FDA efforts towards Regulatory Harmonisation - Transatlantic Trade and Investment Partnership (TTIP) European Health Forum - 3 rd October 2013 Falk Ehmann MD, PhD European Medicines Agency - London
More informationWork plan for the GMP/GDP Inspectors Working Group for 2018
30 November 2017 EMA/INS/GMP/504401/2017 Inspections, Human Medicines Pharmacovigilance & Committees Division Work plan for the GMP/GDP Inspectors Working Group for 2018 Chairperson: Brendan Cuddy Adopted:
More informationWork plan for the GMP/GDP Inspectors Working Group for 2017
13 January 2017 EMA/INS/GMP/584202/2016 Work plan for the GMP/GDP Inspectors Working Group for 2017 Chairperson: David Cockburn Adopted: December 2016 1. Meetings scheduled for 2017 Face-to-face meetings
More informationIssues identified by stakeholders: follow-up from EMA s ATMP workshop
2 February 2017 EMA/48099/2017 Human Medicines Research and Development Support Division On 27 May 2016 EMA hosted a workshop 1 aimed to foster ATMP development and enable expanded patient access in the
More informationImpacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
More informationHealth systems and products Medicinal products authorisations, EMA. PHARMACEUTICAL COMMITTEE 23 October st meeting SUMMARY RECORD
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, EMA PHARM 639 PHARMACEUTICAL COMMITTEE 23 October 2013 71 st meeting SUMMARY
More informationOverview of the Agency s role, activities and priorities for An agency of the European Union
Overview of the Agency s role, activities and priorities for 2015 An agency of the European Union The Agency's prioroties for 2015 In light of the above influences and other business-environment factors,
More informationEMA role in GMP Manufacturing and Quality Compliance
EMA role in GMP Manufacturing and Quality Compliance III all Russian GMP Conference Kazan 2018, Russia Presented by Roberto Conocchia Manufacturing and Quality Compliance European Medicines Agency An agency
More informationBetween Biosimilars and PRIME: EMA s report on regulatory trends and priorities for biopharmaceutical products
Between Biosimilars and PRIME: EMA s report on regulatory trends and priorities for biopharmaceutical products Dr Veronika Jekerle, Specialised Scientific Disciplines, EMA, London, UK CASSS-CMC Forum,
More informationEuropean Regulations for Medicines Place and Role of the EDQM and the European Pharmacopoeia
European Regulations for Medicines Place and Role of the EDQM and the European Pharmacopoeia Cathie VIELLE Head of the Ph. Eur. Department, EDQM Structure Council of Europe, European Union and EDQM The
More informationPPTA Regulatory Workshop June 13, 2016
PPTA Regulatory Workshop June 13, 2016 W. BRYAN SILVEY W. Bryan Silvey is the Senior Director, Global Regulatory Affairs/CMC for Baxalta US Inc. He is located at Baxalta s Westlake Village California regional
More informationPost-approval Change Management Protocols - Current Status and Next Steps on the Way towards a Global Tool
Post-approval Change Management Protocols - Current Status and Next Steps on the Way towards a Global Tool Dr. Markus Goese Lead EU CMC Regulatory Policy F. Hoffmann-La Roche Ltd, Basel - Switzerland Presentation
More informationExplanatory note on fees payable to the European Medicines Agency
30 March 2015 EMA/167155/2014 Executive Director Explanatory note on s payable to the European Medicines Agency The s, exemptions and definitions described in this Explanatory Note apply as of 1 April
More informationInternational Supply Chain: How are we handling globalisation? GCP oversight
International Supply Chain: How are we handling globalisation? GCP oversight Susana Almeida, PhD Senior Director, European Operations Inflamax Research (Canada) patients quality value sustainability partnership
More informationThe role of patients at the EMA
The role of patients at the EMA Nathalie Bere Patient relations coordinator / European Medicines Agency An agency of the European Union What is the European Medicines Agency (EMA) The EMA is the EU regulatory
More informationEMA/CAT support to ATMP developers
EMA/CAT support to ATMP developers CAT-ISCT Workshop: Challenge and opportunities for the successful development and approval of Advanced Therapy Medicinal Products. Presented by Patrick Celis on 25 September
More informationCASSS CMC Strategy Forum EU Introduction to EBE Satellite Session
CASSS CMC Strategy Forum EU 2015 - Introduction to EBE Satellite Session Copenhagen - May 4, 2015 Dr. Markus Goese, Lead EU CMC Regulatory Policy F. Hoffmann - La Roche Ltd, Basel FROM SORRENTO TO COPENHAGEN:
More informationTHE PACMP STRATEGY. March 13-16, 2018
THE PACMP STRATEGY FDA/Xavier PharmaLink Conference 2018 March 13-16, 2018 Ajay Pazhayattil, Director- Pharmaceutical Development, AvacaPharma Inc., Vienna, VA ajay.pazhayattil@avacapharma.com PACMP ICH
More informationIMPLEMENTATION OF THE EU FALSIFIED MEDICINES DIRECTIVE, 2011/62/EU. IPA/EDQM/WHO 2012, Mumbai
IMPLEMENTATION OF THE EU FALSIFIED MEDICINES DIRECTIVE, 2011/62/EU from the perspective of Indian manufacturers and Indian authorities IPA/EDQM/WHO 2012, Mumbai S.M.MUDDA Micro Labs Limited, Bangalore
More informationSupervision of manufacturers: What is expected of National Competent Authorities?
Supervision of manufacturers: What is expected of National Competent Authorities? Fergus Sweeney, PhD, European Medicines Agency Head, Compliance and Inspections EU 28: Science, Medicines, Health Dubrovnik,
More informationAn overview of international initiatives in the regulatory sphere
The place of the Certification Procedure in the global regulatory environment 19/20 September 2017, Prague, Czech Republic An overview of international initiatives in the regulatory sphere Cordula Landgraf
More informationEU regulatory tools for expedited antibacterial development programmes
EU regulatory tools for expedited antibacterial development programmes Expediting antibacterial development: core lessons key tools for a rocky road, ECCMID 2018, Madrid Presented by Marco Cavaleri on
More informationQuestions And Answers To Support The
Questions And Answers To Support The Implementation Of The Pharmacovigilance Legislation - Update This Question and answers section gives advice on regulatory issues in on the interpretation and implementation
More informationQbD approach and Regulatory Challenges in Europe
QbD approach and Regulatory Challenges in Europe DIA 26th Annual EuroMeeting, Vienna 2014 Dr Peter Richardson Head of Quality, European Medicines Agency An agency of the European Union Disclaimer The views
More informationThe European Medicines Agency: A well-established Agency of the EU protecting human and animal health for all EU citizens
14 July 2016 EMA/457243/2016 The European Medicines Agency: A well-established Agency of the EU protecting human and animal health for all EU citizens 1. Who we are The European Medicines Agency (EMA)
More informationScientific advice and its impact on marketing authorisation application reviews
Scientific advice and its impact on marketing authorisation application reviews SME info day: Tools to support innovative medicines development and early access Presented by Jan Regnström, MD, PhD Scientific
More informationICH Q12 : A Unique Opportunity to Realize 21st Century Quality Vision
ICH Q12 : A Unique Opportunity to Realize 21st Century Quality Vision Moheb M. Nasr 3rd FDA/PQRI Conference March 22, 2017 Disclosures The speaker is solely responsible for the content of this presentation
More informationIntroduction and Update on ICH Q12 Guideline Dr Frank Montgomery, Global Head, Reg CMC, AstraZeneca/Medimmune Q12 EFPIA Expert
Introduction and Update on ICH Q12 Guideline Dr Frank Montgomery, Global Head, Reg CMC, AstraZeneca/Medimmune Q12 EFPIA Expert CMC Strategy Forum Japan 2016 6 th Dec 2016 Outline Q12 Scope and Objectives
More informationMarketing Authorisation Routes in the EU
Marketing Authorisation Routes in the EU The EU medicines regulatory system and the European Medicines Agency: an introduction for international regulators and non-governmental organisations 18 September
More informationExplanatory note on fees payable to the European Medicines Agency
09 December 2013 EMA/458574/2013 Executive Director Explanatory note on s payable to the European Medicines Agency The s, exemptions and definitions described in this Explanatory Note apply as of 1 January
More informationABPI response to European Commission consultation on advanced therapy medicinal products
ABPI response to European Commission consultation on advanced therapy medicinal products 28 March 2013 ABPI response to European Commission consultation on the regulation of advanced therapy medicinal
More informationHow are medicines evaluated at the EMA
How are medicines evaluated at the EMA Presented by: Nathalie Bere Patient interaction / Stakeholders and communication Division An agency of the European Union The European System Centralised Procedure
More informationExplanatory note on general fees payable to the European Medicines Agency
Explanatory note on general fees payable to the European Medicines Agency The fees, fee exemptions and definitions described in this explanatory note apply as of 1 June 2017 and are based on Council Regulation
More informationCooperation between regulators in Africa experience from the EU system. Pretoria Dr Tomas Salmonson. Chair, CHMP, EMA, UK
Cooperation between regulators in Africa experience from the EU system Pretoria 2015 Dr Tomas Salmonson Chair, CHMP, EMA, UK Outline of presentation Introduction the European context European Medicines
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. Health systems and products Medicinal products authorisations, EMA Head of Unit
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, EMA Head of Unit PHARM 606 PHARMACEUTICAL COMMITTEE 28 March 2012 68 th meeting
More informationMonthly statistics report: December 2017
19 January 2018 EMA/39932/2018 Information Management Division Medicinal products for human use (cumulative figures for the year to date) This document provides current information related to the volume
More informationMonthly statistics report: November 2016
7 December 2016 EMA/819205/2016 Information Management Division Medicinal products for human use (cumulative figures for the year to date) This document provides current information related to the volume
More informationAdvanced Therapies in Europe
Advanced Therapies in Europe 1 ATMPs in Europe (2009-2017) ~ 500 clinical trials using ATMPs in EU ~ 270 ATMP classifications 18 MAAs reviewed ~ 250 scientific advice requests 9 ATMPs approved 2 3 withdrawn
More informationPharmacovigilance: Information systems and services
Pharmacovigilance: Information systems and services Supporting business activities of the revised pharmacovigilance legislation through better information systems An agency of the European Union To deliver
More informationWork programme Adopted by the Management Board on 18 December December 2014 EMA/773839/2014 Rev. 1 Management Board
18 December 2014 EMA/773839/2014 Rev. 1 Management Board Work programme 2015 Adopted by the Management Board on 18 December 2014 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationExplanatory note on general fees payable to the European Medicines Agency
Explanatory note on general fees payable to the European Medicines Agency The fees, fee exemptions and definitions described in this explanatory note apply as of 1 June 2017 and are based on Council Regulation
More informationOptimising the management of post-approval changes for patients timely access to medicines
Optimising the management of post-approval changes for patients timely access to medicines The industry perspectives with a Pledge for Convergence 7th APAC, April 2018 Sannie Chong (Ph.D. FRSC) Asia Pacific
More informationACG Public Forum. Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD. Monday, 12:45 pm 2:15 pm
ACG Public Forum Join ACG, the FDA, and EMA for a discussion on biosimilars and IBD Monday, 12:45 pm 2:15 pm ACG 2017: FDA-EMA workshop on biosimilars Joachim Musaus EMA Product Lead Gastroenterology Human
More informationConsiderations on regulatory aspects
Considerations on regulatory aspects Regulatory framework for medicinal products in the context of therapeutic use of bacteriophages EMA Workshop on 8 June Presented by Zigmars Sebris on 8 June 2015 Regulatory
More informationLife Cycle Management of Biotech Products An Industry Perspective. Thomas Schreitmueller
Life Cycle Management of Biotech Products An Industry Perspective Thomas Schreitmueller Co chair FIFARMA Regulatory WG Vision and Mission Vision To be the regional voice of the innovative pharmaceutical
More informationICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective
ISPE Japan Affiliate 2016 Annual Meeting, April 14-15, 2016, Tower hall Funabori, Tokyo, Japan ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective Yasuhiro Kishioka, Ph.D. Principal
More informationRecent update of the guidance for Parallel EMA/FDA scientific advice
Recent update of the guidance for Parallel EMA/FDA scientific advice Industry stakeholder platform on research and development support, 15.11.2017 Presented by Thorsten Vetter An agency of the European
More informationChapter 28 Pharmaceutical acquis (human and veterinary medicinal products)
Chapter 28 Pharmaceutical acquis (human and veterinary medicinal products) Screening meeting with Serbia 5 December 2014 DG SANTE D5: Medicinal products - authorisations, EMA; D6: Medicinal products -
More informationStrengthening the prospective discussions on post-licensing evidence generation
Strengthening the prospective discussions on post-licensing evidence generation Industry stakeholder platform on research and development support Presented by Jane Moseley on Senior Scientific Officer
More informationICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Møde i Industrifarmaceut foreningen 15/
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Møde i Industrifarmaceut foreningen 15/11 2018 Nanna Aaby Kruse Team Manager, Biologics. BWP Vice-chair.
More informationAdvantages, Opportunities & Challenges of Adopting the Post Approval Change Management Plan (PACMP)
Advantages, Opportunities & Challenges of Adopting the Post Approval Change Management Plan (PACMP) Quality Forum September 2018 roger nosal, Vice President & Head Worldwide Safety & Regulatory - Global
More informationTrack III: International Clinical Trials: Global Compliance Norms and EU Focus
Track III: International Clinical Trials: Global Compliance Norms and EU Focus EU Focus Emmanuelle Voisin, PhD Principal, Voisin Consulting May 2008 Rationale Clinical trials in EU important part of health
More informationPractical implementation of the Falsified Medicines Directive
Practical implementation of the Falsified Medicines Directive Belén Escribano Romero Head of Pharmaceutical Inspection and Enforcement Department AEMPS 1 Content Development of the Directive Overview of
More informationDrug Registration in BRICS countries: Opportunities and Challenges. Judith ter Horst 1 November 2018
Drug Registration in BRICS countries: Opportunities and Challenges Judith ter Horst 1 November 2018 Once a drug reaches Phase1, it s a good idea to start discussions with global regulatory authorities
More informationFIFARMA Position: Transparency in regulatory decision making on the approval for biosimilar products
FIFARMA Position: Transparency in regulatory decision making on the approval for biosimilar products CASSS LATAM Forum, Sep 5-6, Mexico City Thomas Schreitmueller, Co-chair FIFARMA Regulatory and Biologics
More informationWork programme July 2016 EMA/92499/2016 Rev. 1 1 Executive Director. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
5 July 2016 EMA/92499/2016 Rev. 1 1 Executive Director 1 Procurement plan added (annex 5) 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20
More informationContent. Introduction: Approval of ATMPs. Support to ATMP developers. Role of EMA and National Competent Authorities
Content Introduction: Role of EMA and National Competent Authorities Approval of ATMPs What are ATMPs? Centralised procedure Support to ATMP developers 1 Introductory statements This talk is on marketing
More informationPharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA
Pharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA 1 2 ND MENA Regulatory Conference On Bioequivalence, Biowaivers, Bioanalysis, Dissolution & Biosimilars
More informationPharmacovigilance. An agency of the European Union
Pharmacovigilance An agency of the European Union Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine-related
More informationA holistic regulatory approach to accelerated CMC development
A holistic regulatory approach to accelerated CMC development Seán Barry Ph.D Pharmaceutical Assessor Health Products Regulatory Authority CMC Strategy Forum 2017 Disclaimer: The opinions expressed are
More informationClinical Development and enabling Regulatory Steps: How to obtain ODD and Scientific Advice at EMA
Clinical Development and enabling Regulatory Steps: How to obtain ODD and Scientific Advice at EMA TELETHON Convention, Riva del Garda (TN) 15 March 2017 Michela Gabaldo Head Alliance Management & Regulatory
More informationGuidance on preparing for Brexit in the centralised procedure
Guidance on preparing for Brexit in the centralised procedure SME info day: Regulatory toolbox for medicines and combined devices developers Presented by Leonor Enes on 26 October 2018 SME Office, Stakeholders
More informationICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Keith O. Webber, Ph.D. Sr. Director, Global Regulator Affairs Rx Perrigo Company, plc Q U A L I T Y A F F
More informationEngagement with stakeholders
Engagement with stakeholders 2 nd International Awareness Session - The EU medicines regulatory system and the European Medicines Agency Presented by Juan Garcia Burgos and Marie-Helene Pinheiro on 8 March
More informationImpacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Empaques Primarios y Tendencias Farmaceuticas para Inyectables 1 International Support Support in R&D Technology Transfer
More informationApplying for EU marketing authorisation. For medicinal products for human use. An agency of the European Union
Applying for EU marketing authorisation For medicinal products for human use An agency of the European Union Medicines can be authorised throughout the EU by means of a single application procedure. The
More informationEMA Regulatory Science to 2025
23 October 2018 EMA/723198/2018 Scientific Committees Regulatory Science Strategy EMA Regulatory Science to 2025 Reference documents Reference material 30 Churchill Place Canary Wharf London E14 5EU United
More informationCurrent Hotspots during CMC Evaluation a European Regulatory Perspective
www.pei.de Current Hotspots during CMC Evaluation a European Regulatory Perspective CMC Strategy Forum Japan 2018 3-4 December, Tokyo Steffen Gross, Head Section monoclonal - and polyclonal Antibodies
More informationUpdate of AHC Activities. Kui Lea Park, Ph.D Director, Center for Drug Development Assistance, KFDA APEC Harmonization Center
Update of AHC Activities Kui Lea Park, Ph.D Director, Center for Drug Development Assistance, KFDA APEC Harmonization Center November 13 th, 2012 Contents I Overview of 2012 Activities II Planning of 2013
More informationThe European Agency for the Evaluation of Medicinal Products Work Programme 2003
The European Agency for the Evaluation of Medicinal Products Work Programme 2003 Adopted by the Management Board on 19 December 2002 The Work Programme for 2003 is presented by the Executive Director to
More informationfact sheet 7 Regulator Capacity for Biologics in Low-and- Middle Income Countries
fact sheet 7 Regulator Capacity for Biologics in Low-and- Middle Income Countries International Alliance of Patients Organizations CAN Mezzanine 49-51 East Road London N1 6AH United Kingdom International
More informationImpact of EU GMPs on Australian GMP. Trevor Schoerie PharmOut
Impact of EU GMPs on Australian GMP Trevor Schoerie PharmOut Part I Basic Requirements for Medicinal Products Current TGA Version, 7 years out of date TGA are actively and publically talking about PE009-0813
More informationOverview of global registration of vaccines
Overview of global registration of vaccines by Dr. Nora Dellepiane Workshop: Global Registration and Vaccine Shortage Taipei, Taiwan 6 to 10 March 2017 Outline of the presentation The objective of medicines
More informationKFDA Regulatory Framework on Biopharmaceuticals - Focus on Biosimilar
KFDA Regulatory Framework on Biopharmaceuticals - Focus on Biosimilar Kyung-Min Baek, Ph.D. Recombinant Protein Products Division Korea Food and Drug Administration(KFDA) Biopharmaceuticals A biopharmaceutical
More informationKorean and APEC Perspectives: Recent trends in the regulation of biotherapeutics
Korean and APEC Perspectives: Recent trends in the regulation of biotherapeutics Jeewon Joung Ministry of Food and Drug Safety Republic of Korea Outline I. Korean Regulatory updates for Biotherapeutics
More informationBrexit Guidance for Stakeholders Human and veterinary medicines
Brexit Guidance for Stakeholders Human and veterinary medicines DATE: 03 JANUARY 2018 V.2 This guide does not purport to be an interpretation of law and/or regulations. The content provided is subject
More information6th EUROPEAN CONFERENCE ON RARE DISEASES & ORPHAN PRODUCTS ECRD 2012 Brussels
www.eurordis.org 6th EUROPEAN CONFERENCE ON RARE DISEASES & ORPHAN PRODUCTS ECRD 2012 Brussels Brussels, 24-25 May 2012 www.eurordis.org THE NEW PARADIGMS OF RARE DISEASES TREATMENT DEVELOPMENT & ACCESS
More informationEU health policy. Strategy for the pharmaceutical industry and biosimilars. Salvatore D'Acunto. DG Research. DG Internal Market. DG Health & Consumers
Strategy for the pharmaceutical industry and biosimilars Salvatore D'Acunto European Commission Enterprise and Industry Directorate-General London, 3 April 2014 EU health policy DG Research R&D, innovation
More informationOverview of comments received on 'Draft Guideline on manufacture of the finished dosage form'
14 July 2017 EMA/CHMP/QWP/104223/2016 Committee for Medicinal Products for Human Use (CHMP) Overview of comments received on 'Draft Guideline on manufacture of the finished dosage form' (EMA/CHMP/QWP/245074)
More informationWork plan for the Biostatistics Working Party (BSWP) for 2018
14 December 2017 EMA/CHMP/333668/2017 Work plan for the Biostatistics Working Party (BSWP) for 2018 Chairperson: Anja Schiel Status of the work plan: December 2017 Adopted The activities outlined in the
More informationRecent experience in scientific advice and marketing authorisations
Recent experience in scientific advice and marketing authorisations Presented by Brigitte Brake on 16 April 2015 BfArM & BWP, Germany An agency of the European Union Introduction Short introduction to
More informationto protect human health throughout the life-cycle of medicinal products;
ICMRA Communications Strategy: 2018-2020 Introduction The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, highlevel, strategic coordinating, advocacy and leadership
More informationRegulatory Update. Paul Sexton. QP Forum
Regulatory Update Paul Sexton QP Forum 16 th April, 2015 Content Updates on GMP Guidance Updates on EU Legislation Draft Ph Eur monograph on WFI including RO 2 Chapter 5 - Production Paragraphs 27 to 30
More informationThis video gives an overview of the centralised procedure at the European Medicines Agency
This video gives an overview of the centralised procedure at the European Medicines Agency In Europe today, all medicines must have a marketing authorisation before they can be used by patients And there
More informationImplementation of EU Falsified Medicines Directive
Implementation of EU Falsified Medicines Directive Gerald W Heddell Director, Inspection, Enforcement & Standards Division 26th Annual EuroMeeting 25-27 March 2014 ACV, Vienna Austria Disclaimer The views
More informationWe appreciate the opportunity to submit these comments for your consideration.
February 28, 2018 European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom via email to rp-stats-qa@ema.europa.eu Dear Sir or Madam: The International Society for Pharmaceutical
More informationWork programme October 2017 EMA/583016/2016 Rev.1 1 Executive Director. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
9 October 2017 EMA/583016/2016 Rev.1 1 Executive Director 1 Project added to 2017 work programme, chapter 4: Support and governance activities 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
More informationTECHNICAL AND REGULATORY ASPECTS OF PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT: ICH Q12
TECHNICAL AND REGULATORY ASPECTS OF PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT: ICH Q12 MOHEB NASR PHRMA ICH Q12 TOPIC LEAD WCBP 2018 JANUARY 31, 2018 WASHINGTON, D.C. DISCLAIMERS The speaker is solely
More informationInternational Regulatory Convergence
International Regulatory Convergence - Is Enough Being Done? Bob Tribe, 11 July 2016 1 Why Improve Regulatory Convergence? Many different efforts promoting regulatory convergence. These efforts are fragmented
More informationThe pessimist sees difficulty in every opportunity, the optimist sees the opportunity in every difficulty. Churchill, Winston
The pessimist sees difficulty in every opportunity, the optimist sees the opportunity in every difficulty. Churchill, Winston Expectations are same: Safety Efficicacy GMP compliance Profile attribute Population
More informationInternational Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot
15 January 2015 EMA/789664/2014 International Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot Information package on Participation in the Information Sharing Pilot for the Evaluation
More informationFormat and content of electronic periodic safety update reports (Technical contribution to EC implementing measure)
Format and content of electronic periodic safety update reports (Technical contribution to EC implementing measure) First Stakeholders Forum on the implementation of the new Pharmacovigilance legislation,
More informationCLINICAL TRIAL MANAGEMENT & REGULATORY AFFAIRS in Pharma, Biotech, Medtech Domains
CLINICAL TRIAL MANAGEMENT & REGULATORY AFFAIRS in Pharma, Biotech, Medtech Domains May 10-12, 2016 at EPFL, Odyssea Building, level minus 1, classroom -1 0021 Module Leaders Thomas Girard, Regulatory Affairs
More informationOptimising early access tools: Revision of the guidelines on Accelerated Assessment and Conditional Marketing Authorisation
Optimising early access tools: Revision of the guidelines on Accelerated Assessment and Conditional Marketing Authorisation High-level overview of comments received during the public consultation Presented
More informationNew pharmacovigilance systems and services
New pharmacovigilance systems and services 17 September 2015, PCWP/HCPWP joint meeting Presented by Peter Arlett, Head of Pharmacovigilance department An agency of the European Union Background The new
More informationThemes & Key Points The Problem Statement
Themes & Key Points The Problem Statement Post-approval changes are inevitable and essential, however, it is difficult to manage evolving requirements and timelines in every country to ensure continuous
More informationStakeholders engagement
Stakeholders engagement The EU medicines regulatory system and the European Medicines Agency: an introduction for international regulators and non-governmental organisations 18-19 September 2017 Presented
More information