IBC Life Sciences, Hotel Okura, Amsterdam
2005-06-20 - 2005-06-21
Day One: 20 June 2005Keynote Session Paper 1: Current status of eCTD in Europe: Specification 1.0 update
Proposed Speaker: Dr Stan van Belkum, Process Manager for Pharmacotherapeutic Group III, Medicines Evalution Board, The Netherlands Paper 2: eCTD A US regulators update and guidance
Proposed Speaker: Gary Gensinger, Director, Review Technology Staff, Office of Information Management CDER, FDA Paper 3: The impact on eCTD on the publisher: Will the role of the publisher change?
Confirmed Speaker: Hans van Bruggen, Associate Director Regulatory Operations, Centocor Regulatory Affairs Centocor Europe, The Netherlands
Preparing and Submitting the eCTD: Real Life Experiences and Challenges
Paper 4: Achieving eCTD submissions in Europe: Pharma case study
Proposed Speaker: A Representative, Johnson and Johnson Paper 5: Achieving eCTD submissions in Europe: Generics/ biotech case study
Proposed :Ron de Boer, Regulatory Affairs Associate, Multipharm – Novartis CGDE, The Netherlands (tentative) Paper 6: Achieving eCTD submissions in the US: Pharma case study
Confirmed Speaker: Terri Booth-Genthe, MS, Associate Director II, WWRA
Wyeth Research , USA Paper 7: Regulators feedback: Experiences of eCTD submissions to date
Confirmed Speaker: Klaus Mengues, BfArM, Germany Paper 8: Outsourced approach to submitting eCTD: case study
Confirmed Speakers: Neil Edwards, Associate Director, Worldwide Regulatory Affairs, PAREXEL International Corporation & Shylendra Kumar, President & CEO Datafarm Inc., USA Paper 9: Preparing a paper copy of an eCTD for the EU
Confirmed Speaker: Tracy Baldwin, Associate Director Worlwide Regulatory Operations, Pfizer, UK Day Two: 21 June Latest information on PIM, SPL and Application forms Paper 1: Product Information Management (PIM) in the European Centralised
Procedure. The Implementation Plan
Confirmed Speaker: Andrew P Marr, European Union EFPIA Paper 2: Overview of the SPL project (structure product labelling)
Proposed Speaker: A Representative, First Consulting Paper 3: Electronic application forms: How they have been developed, what are the standards, how are they maintained
Confirmed Speaker: Miguel Blay, AFSSAPS Implications and consequences of working with eCTD: Life Cycle Management, Document Management and Archiving Paper 4: Product life-cycle Management: Life cycle of a document, life cycle of the submission, life cycle of a variation
Confirmed Speaker: Hans van Bruggen, Associate Director Regulatory Operations, Centocor Regulatory Affairs Centocor Europe, The Netherlands Paper 5: Beyond big pharma: Life-cycle management strategies for small and mid-sized pharma
Proposed Speaker: To be announced Paper 6: Data management and archiving: Maintaining data for compliance and profit
Proposed Speaker: To be announced New Initiatives for electronic applications Paper 7: Electronic interaction between industry and the agencies
Confirmed Speaker: David Wheeler, MHRA (tentative) Paper 8: Europharm initiative update
Confirmed Speaker: Gerhard Schluetr, Head Global Regulatory Operations, Bayer Healthcare Pharmaceuticals, Germany
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