Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).

Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. In this audio conference, the speakers discuss lessons learned from industry that were employed to develop customized strategies for keeping up with the associated regulatory, scientific and public health demands.

This audio conference covers:

• Understand the PSUR and recent developments
• Current issues and challenges regarding the preparation of the PSUR
• Ways to ensure compliance
• Strategies to manage resources and ensure cost-effectiveness
• Feedback on related questions

About the speaker:

Dr. Hemendra Misra ,MBBS, M.Med, MSc is a Pharmacovigilance physician with more than thirteen years of international work experience. Dr. Misra’s medical practice includes positions at hospitals in India and with Medecins Sans Frontieres. He gained public health experience as a consultant for a WHO Anti-Malaria program in India, the STB SARS Containment Team in Singapore as well as working for the Health Promotion Board in Singapore. Dr. Misra has more than five years of experience in both Pharma and the CRO Industry. He has been a Medical Monitor for various clinical trials and overseen the pharmacovigilance functions, both in EU and the Asia-Pacific regions. Additional Drug Safety experience includes safety surveillance of marketed products as well as products in development - individual case assessments, signal detection and evaluation, risk management activities as well as preparation of aggregated safety reports and other regulatory documents. Dr. Misra is experienced in a broad range of therapeutic areas including Endocrinology, CVD, Infectious Diseases, Oncology and CNS.

Mark Nelson Tyrrell, B.S., R.Ph., Director, Risk Management, has over seventeen years experience in pharmacovigilance in both Pharma and the CRO industry. His focus for the past 7 years has been in the strategic design and implementation of post-authorization safety surveillance, focused registries and observational studies, and EU-RMP / REMS development. His recent work has focused on risk minimization activities for opiate analgesics and surveillance and evaluation of risk management programs in the European Union and North America. Mark's therapeutic experience is extensive, having provided cognitive pharmacy services to patients in the areas of psychiatry, infections disease, heart failure, diabetes and neurology, as well as directing treatment programs in pain management, clozapine, and warfarin.

Who should attend?

• Regulatory Affairs
• Clinical Research & Development
• Pharmacovigilance
• Risk Management
• Medical Writing