BioPharm Excel

Date:             Thursday, October 4th, 2018

Time:             7.30am-9.30am

Venue:          Clayton Hotel, Burlington Road, Dublin, Ireland

                       (formerly, The Burlington Hotel)

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Don't miss this opportunity to hear a preview of the latest research findings from the FDA Quality Metrics Research (due for publication November 2018) and discuss the importance of assessing and demonstrating the effectiveness of your PQS with a panel of international regulators from the US, Japan and Ireland. We will address the practical tools and metrics to improve oversight and risk reduction in both the internal and external manufacturing network.

With deep knowledge of the FDA's Quality Metrics Initiative, Nuala Calnan is a leading expert on designing effective measures of performance in the Biopharma industry today. As a key member of the St. Gallen University led research team (now in its 3rd year) providing research directly to FDA, Nuala will share a preview of the insights gained from the FDA research and the implications and opportunities for the industry.

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Agenda

7.30am  Light breakfast served

7.45am  Measuring What Matters to Your Patients - 

                Key Insights from the FDA Quality Metrics Research 2016-2018

8.15am   Updates on recent developments and FDA Federal Register Notices

                in relation to Quality Metrics

8.45am   Q & A with the International Regulatory Panel

9.30am   Close

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This highly informative Breakfast Seminar is aimed at:  

• Senior Leaders from across the Biopharma Industry

• Manufacturing and Operations Management

• QA Management and QA Executives responsible for oversight of the PQS

• Business and Operational Excellence professionals

• Compliance and Quality Consultants and Key Service Providers to the Industry

• Regulators, Academics, Government Agencies

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Panel Speakers

Kevin O'Donnell Ph.D, Market Compliance Manager, HPRA

Dr. O’ Donnell is the Market Compliance Manager at the Irish Health Products Regulatory Authority. He is responsible for a number of compliance-related and market-surveillance programs at HPRA, such as the quality defect and recall program and its sampling and analysis activities. Kevin is also a senior GMP Inspector at the HPRA. 

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Yukio Hiyama Ph.D, (Retd.) Scientist at National Institute of Health Sciences (NIHS)

Dr. Hiyama, visiting (retired) Scientist at National Institute of Health Sciences (NIHS), Ministry of Health, Labour and Welfare. He leads MHLW’s study groups to draft GMP related guidance and to propose the regulatory framework. He led an industry-government human science project on evaluation methods for pharmaceutical development and manufacturing control. He has been involved in the ICH discussion for Q8, Q9 and Q10. He is still active in reviewing new drug applications and in participating in JP committees as PMDA’s external expert.

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H. Gregg Claycamp M.S., Ph.D, Senior Biomedical Research Scientist, FDA. 

H. Gregg Claycamp, M.S., Ph.D., is presently a Senior Biomedical Research Scientist, Risk Analysis and Decision Analysis in the FDA Center for Veterinary Medicine. He provides R&D leadership in risk management, particularly risk analysis and decision analysis for human health risks from food animal drugs and risk-based decision making for drug reviews. Dr. Claycamp’s history in risk analysis and quality risk management including serving as the regulatory rapporteur for the final, International Conference for Harmonization Guideline "ICH Q9: Quality Risk Management."