>>Back
Track 1: Process Optimisation
Track 2: Quality
Track 3: Regulatory Affairs
Track 7: Quality
Track 9: Biologics
Track 10: Orphan Drugs (/ Medicinal Products)
Plenary Session Closing: Pharmaceutical Quality and the Future
PDA/EMA - Joint Conference - Regulation, Cooperation, Innovation
- Publisher:
- Publication:2011/4/15
Overview
Dear Colleagues,
PDA and the European Medicine Agency welcome you to the 2011 PDA-EMA Conference in London. Planning for this year’s conference, the fourth in this series, started in May of 2010 with the recruitment of our superb scientific planning committee. The committee has worked over the intervening months to bring you a very special program. The 2011 Conference will be a milestone as there has been a decision to broaden the agenda beyond Good Manufacturing Practice (GMP) to include a full range of quality issues relating to pharmaceutical development, production and quality management. The committee’s input from EMA’s Quality Working Party (QWP), Biologics Working Party (BWP) and GMP/GDP Inspectors Working Group has resulted in substantial CMC-related content in the agenda. The agenda has been extended from 1¾ days to a full 2½ days, and the number of concurrent tracks increased from 3 to 5, to make room for the expanded content. The number of EMA speakers, and speakers from the national health authorities, is impressive due in part to the convenience of the conference venue near London’s Heathrow Airport.
As a result of these efforts we present to you the 2011 PDA-EMEA Conference, with the theme, “Regulation | Cooperation | Innovation: An Effective Partnership between Authorities and Industry in Europe.” The plenary sessions on each morning of the conference will address universal themes of interest to all segments of our business. The five parallel tracks on the afternoons of 3 & 4 May will provide ½ day of coverage to more detailed technical or regulatory topics. The parallel tracks include: Process optimisation, Quality, Regulatory Affairs, Advanced Therapies, Supply Chain, Trends in Manufacturing, Biologics and Orphan Drugs (some tracks are repeated two times). There will be interactive panel discussions capping each of the parallel tracks. The planning committee has also focused on issues of interest to ‘Start-up’ and small & medium enterprises (SME). We have listened to your comments and evaluations from the 2006, 2008 & 2009 conferences, and have structured the agenda in a way to allow ample time for questions, answers and discussion. Full preliminary information can be found below in this preliminary brochure. Please join us in London for this very special and unique opportunity to learn more about the future of pharmaceutical quality, GMP, development and manufacturing in our business.
Dr. Riccardo Luigetti Dr. Lothar Hartmann
European Medicines Agency (EMA) F. Hoffmann-LaRoche
London Basel
European Medicines Agency (EMA) F. Hoffmann-LaRoche
London Basel
Scientific Planning Committee
Co-Chairs
Riccardo Luigetti, EMA (Co-chair)
Lothar Hartmann, F. Hoffmann-La Roche, Switzerland (Co-chair)
Lothar Hartmann, F. Hoffmann-La Roche, Switzerland (Co-chair)
Regulatory Authorities
David Cockburn, EMA
Nick Gate, EMA
Steffen Gross, Paul-Ehrlich-Institut, Germany
Anne Junttonen, FIMEA, Finland
Vassiliki Revithi, EOF, Greece
Peter Richardson, EMA
Jean-Louis Robert, Laboratoire National de Sante, Luxembourg & Head of QWP
Jean-Hugues Trouvin, AFSSAPS, France
Nick Gate, EMA
Steffen Gross, Paul-Ehrlich-Institut, Germany
Anne Junttonen, FIMEA, Finland
Vassiliki Revithi, EOF, Greece
Peter Richardson, EMA
Jean-Louis Robert, Laboratoire National de Sante, Luxembourg & Head of QWP
Jean-Hugues Trouvin, AFSSAPS, France
Industry
Véronique Davoust, Pfizer
Soren Pedersen, NovoNordisk
Jose Luis Ortega Conejero, PharmaMar
Gabriele Gori, Novartis
Frank Hallinan, Pfizer
Barbara Jentges, PhACT
Jose Luis Ortega Conejero, PharmaMar
Gabriele Gori, Novartis
Frank Hallinan, Pfizer
Barbara Jentges, PhACT
PDA Staff
Georg Roessling, PDA Europe
James Lyda, PDA
Robert Dana, PDA
James Lyda, PDA
Robert Dana, PDA
Tracks
Plenary: EMA-Europe Regulatory and Quality Priorities
- EMA Roadplan 2015
- Update on Regulatory, Quality & GMP Guidelines
- Implementation of ICH Q8, Q9 and Q10 – are we going in the right direction?
- Industry Perspective on Partnership with Authorities - Status of the Paradigm Change
Concurrent Tracks 1 - 5
Track 1: Process Optimisation
- Bottle Necks in Supply - Lessons learned from the Pandemic
- Six Sigma and Lean Manufacturing initiatives
- Platform Manufacturing
- Single use of Equipment
Track 2: Quality
- The Role of Quality after the Paradigm Change
- Moving from Compliance to Strategic Quality Management
- Knowledge Management’ – a Mature Concept for the Pharmaceutical Industry
- Lifecycle approach to Process Validation
Track 3: Regulatory Affairs
- Regulatory Harmonization Processes within the EU
- Trends in European Submissions
- How EMA supports submissions
- Paperless Submissions – Current Situation within the EU
Track 4: Advanced Therapy Medicinal Products (ATMP)
- The European Legislative framework for ATMPs
- Industry perspective on applying GMPs for ATMPs
- Is Europe prepared to release Batches of ATMPs – Eligibility and Suitability capabilities of QP
- Hospital Exemption – How to Release Cell-based Products in the European Environment
Track 5: Supply Chain
- Challenges of Sourcing of Raw Materials (Asia Region)
- The practical impact of the Antifalsification legislation
- Ensuring Quality during Transportation
- Securing the supply chain - From Finished Product to Patient
Plenary Session: International Collaboration, Innovation & Progress
- EMA International Collaboration Programs
- How will/should the European Regulatory Network develop within the next 20 years
- The Innovative Medicines Initiative
- The Situation of SME Biological Manufacturers in Europe
- How EMA Support SME’s
Concurrent Tracks 6 - 10
Track 6: Trends in Manufacturing
- New Developments in Pharmaceutical Packaging
- Visual Inspection – New Techniques & Latest Developments
- Freeze Drying
- NIRS – Revised EMA Guideline and the Regulatory Impact
Track 7: Quality
- New Guideline on Pharmaceutical Development of Paediatrics
- Implementation of Genotoxic Impurities Guideline
- API Audits
- Quality as Competitive Advantage
Track 8: Regulatory Affairs
- Experiences with the new EU Variations Regulations
- Comparison of EU and US Regulatory Change Requirements
- ‘Biologicals’ in Registration – Dossier Optimisation
- Filing a dossier using QbD (including Real Time testing) – Case Study
Track 9: Biologics
- Adventitious Viruses – current testing developments
- The new GMP Annex 2 – Consequences for European Manufacturers
- EMA Guideline on the Requirements for Quality Documentation Concerning Biological IMPs
- Comparability versus Filtration
Track 10: Orphan Drugs (/ Medicinal Products)
- Regulatory Environment of Orphan Medicinal Product in the EU
- Procedural Steps for Orphan Drug Designation (ODD)
- Orphan Drug Designation (ODD) – Cooperation between EU and US
- View of an Orphan Medicinal Product Manufacturer – Challenges regarding Quality Requirements
Plenary Session Closing: Pharmaceutical Quality and the Future
- Challenges for Industry: Managing Quality in a Globalised Market
- The Borderline between GMP and Submissions – Collaboration between Assessors and Inspectors
- Quality Issues in the next 25 Years for Biological Medicinal Products?
- Personalised Medicines -The future of Pharmaceutical Manufacturing
Source:PDA