9th Annual Biomarkers Congress
Pharmacovigilance and Risk Management Strategies 2011

Schedule of Presentations:

Sunday, January 9, 2011
07:30:00 TUTORIAL REGISTRATION
08:25:00 TUTORIAL #1 | Signal Detection, Case Assessment, and Data Mining in Pharmacovigilance: Current State of the Art Sheila Weiss Smith, Sally Van Doren
08:30:00 TUTORIAL #2 | Periodic Safety Update Reports (PSURs): A Guide to the Construction and Analysis of PSURs, ASRs, and DSURs Stanley B. B. Garbus
09:00:00 TUTORIAL #5 | How to Prepare for a Safety Inspection Barton L. Cobert
12:00:00 LUNCH BREAK | (Lunch will not be provided.)
13:30:00 TUTORIAL #3 | Applying MedDRA® in Clinical Safety and Pharmacovigilance Sonja Brajovicu, Judy E. Harrison
13:30:00 TUTORIAL #4 | Pharmacovigilance and Risk Management Planning Brande L. Ellis, Indiana M. Strombom, Valerie E. Simmons
17:00:00 TUTORIALS ADJOURN
Monday, January 10, 2011
07:30:00 CONTINENTAL BREAKFAST AND ATTENDEE REGISTRATION
08:30:00 WELCOME AND OPENING REMARKS Steve Jolley, Annette Stemhagen
08:45:00 KEYNOTE PRESENTATION | Impact of Risk Management Programs: Patient Perspective Nancy J. Norton
09:30:00 REFRESHMENT BREAK
09:55:00 SESSION 1 | Pharmacovigilance and Medical Product Safety: International Perspectives
10:00:00 SESSION 1 – Part A | Pharmacovigilance and Medical Product Safety: European Perspectives Valerie E. Simmons
10:05:00 SESSION 1 – Part A | Where We Are and Where We Are Going in Europe – WEBINAR PRESENTATION Peter Arlett
10:30:00 SESSION 1 – Part A | Medicines and Healthcare products Regulatory Agency (MHRA) Pre- and Postmarketing Regulatory Update
11:00:00 SESSION 1 – Part B | Pharmacovigilance and Medical Product Safety: Asian Perspectives E. Stewart Geary
11:05:00 SESSION 1 – Part B | Pre- and Postmarketing Regulatory Update from Japan Tomoko Okudaira
11:30:00 SESSION 1 – Part B | Overview of the Regulatory System in China R Wang
12:00:00 SESSION 1 – Part B | Ask the Experts – Question and Answer Panel Valerie E. Simmons, E. Stewart Geary
12:30:00 LUNCHEON
13:45:00 SESSION 1 – Part C | Pharmacovigilance and Medical Product Safety: US Perspectives Toni Piazza Hepp
13:45:00 SESSION 1 – Part C | Center for Drug Evaluation and Research (CDER) Pre- and Postmarketing Update Gerald J. Dal Pan
14:30:00 SESSION 1 – Part C | Center for Devices and Radiological Health (CDRH) Pre- and Postmarketing Jonathan Sackner-Bernstein
15:15:00 REFRESHMENT BREAK
15:45:00 SESSION 1 – Part C | Ask the Experts – Question and Answer Panel Toni Piazza Hepp
16:30:00 DAY 1 SUMMARY
17:00:00 NETWORKING RECEPTION
Tuesday, January 11, 2011
07:30:00 REGISTRATION AND CONTINENTAL BREAKFAST
08:25:00 SESSION 2 | Early Understanding of Clinical Safety and Risk
08:30:00 SESSION 2 | Overview of Clinical Development William W. Gregory
08:40:00 SESSION 2 – Part A | Nonclinical Safety Data William W. Gregory
08:45:00 SESSION 2 – Part A | What Studies Are Needed? How to Evaluate and Review the Study Protocols for Safety and Risk? Weighing the Benefi t Risk Lewis Kinter
08:50:00 SESSION 2 – Part A | Correlation of Nonclinical Safety Findings to Clinical Findings: The Work of the Health and Environmental Sciences Institute James H Kim
10:00:00 REFRESHMENT BREAK
10:25:00 SESSION 2 – Part B | Premarketing Assessment of Drug Safety Mariette Boerstoel-Streefland
10:30:00 SESSION 2 – Part B | A Focus on the DSUR Ellis Unger
11:00:00 SESSION 2 – Part B | Signaling in Clinical Trial Safety Data Janet E. Scott
11:30:00 SESSION 2 – Part B | FDA Perspective: Premarketing Assessment of Drug Safety – Safety Profi les, ISS, Risk Assessment, Safety Specifi cations Robert J. Temple
12:00:00 SESSION 2 – Part B | Ask the Experts – Question and Answer Panel Mariette Boerstoel-Streefland
12:30:00 LUNCHEON
13:30:00 SESSION 3 | Safety Consideration when Developing a Proprietary Name Steve Jolley
13:45:00 SESSION 3 | FDA Perspective Carol Holquist
14:00:00 SESSION 3 | Industry Perspective
14:30:00 REFRESHMENT BREAK
15:00:00 SESSION 4 | Drug Safety and Pharmacovigilance Inspections: FDA, European Union, and Japanese Approaches Steve Jolley
15:15:00 SESSION 4 | FDA Approach
15:30:00 SESSION 4 | EU Approach Manjit Virdeeuuu
15:45:00 SESSION 4 | Japanese Approach H Kobayashi
16:30:00 SESSION 4 | Ask the Experts – Question and Answer Panel Steve Jolley
Wednesday, January 12, 2011
07:30:00 REGISTRATION AND CONTINENTAL BREAKFAST
08:25:00 SESSION 5 | Current Approaches to Pharmacovigilance and Risk Management
08:30:00 SESSION 5 – Part A | Developments in Benefi t Risk Management Planning Valerie E. Simmons
08:35:00 SESSION 5 – Part A | What Are REMS and RMPs - The Diff erences Between the Requirements for REMS and RMPs Valerie E. Simmons
09:00:00 SESSION 5 – Part A | Globalizing RMP Activities: Reconciling the Diff erences Judith W. Zander
09:30:00 SESSION 5 – Part A | Current State of Benefi t Risk Analysis Rebecca A. Noel
10:00:00 SESSION 5 – Part A | Assessing Eff ectiveness: What Are the Challenges in Assessing the Eff ectiveness of RMPs and REMS Philippe Van der Auwera
10:30:00 REFRESHMENT BREAK
11:00:00 SESSION 5 – Part B | Beyond Spontaneous Reporting Annette Stemhagen
11:05:00 SESSION 5 – Part B | Signaling Recommendation from CIOMS 8 Manfred Hauben
11:30:00 SESSION 5 – Part B | Balance Between the Use of Automated Signal Detection Methods and the Need to Engage the Prepared Mind Steve Jolley
12:00:00 SESSION 5 – Part B | Maximizing the Utility of Observational Studies Kelly D. Davis
12:30:00 LUNCHEON
13:30:00 SESSION 5 – Part C | Analysis of Health Care Data Annette Stemhagen
13:35:00 SESSION 5 – Part C | FDA Sentinel Initiative
14:00:00 SESSION 5 – Part C | Observational Medical Outcomes Partnership Jonathan Morris
14:30:00 SESSION 5 – Part C | Q&A/Panel Discussion
15:00:00 SESSION 5 – Part C | Ask the Experts – Question and Answer Panel Wenda K. Brennan
15:30:00 CONFERENCE ADJOURNS
4th Annual Pharma R&D Asia Congress
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