Risk Management in Pharmacovigilance Dinner Course, May 10, 2016, Boston, MA

NEEDHAM, Mass. - April 6, 2016 - PRLog -- Cambridge Healthtech Institute (CHI) announces details for a dinner short course, "Risk Management in Pharmacovigilance - Bridging Clinical Drug Development," to be held at its fifth annual Clinical Trial Innovation Summit. The course is scheduled on May 10, 2016 at 5:30-8:30 pm at the Westin Boston Waterfront Hotel in Boston, MA.

This intensive workshop explores current opportunities made possible by the legislation, advances in information technology and a new scientific methodology to enhance and modernize approaches for risk management in the drug development and smooth planning for the peri-approval and post-approval periods. Based on the current regulatory thinking about the benefit/risk assessment methodologies, participants will learn how to take advantage of the safety and efficacy follow-up options given by the EU and US law and guidelines.

Key Learning Objectives:

-- Understand key aspects of benefit/risk methodologies used by EU and USA regulatory agencies

-- Manage expectations regarding safety and efficacy follow-up systems for various types of drug products

-- Improve usage of the tools bridging the clinical drug development program with the life-cycle management, such as development risk management planning, Development Safety

Update Reports (DSURs), Periodic Benefit-Risk Evaluation Report (PBRERs), and Risk Management Plans (RMPs).

Instructors:

Jan Petracek, MD, MSc, CEO, European PharmInvent Services

Marina Malikova, PhD, MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

Dinner will be served.

For additional information and to register, visit http://www.clinicaltrialsummit.com/ctl_content.aspx?id=15...

About Clinical Trial Oversight Summit

Cambridge Healthtech Institute's Fifth Annual Clinical Trial Innovation Summit will bring together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The 2016 program focuses on key issues and opportunities in the clinical trial industry, including patient recruitment, site selection, data integration, mobile technologies, project management, outsourcing, budgeting, quality in trial conduct, risk-based monitoring and auditing. www.clinicaltrialsummit.com

About Cambridge Healthtech Institute (CHI)

Cambridge Healthtech Institute (CHI), a division of Cambridge Innovation Institute, is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech, CROs, academia, and niche service providers. CHI is renowned for its vast conference portfolio held worldwide including PepTalk, Molecular Medicine Tri-Conference, SCOPE Summit, Bio-IT World Conference & Expo, PEGS Summit, Drug Discovery Chemistry, Biomarker World Congress, World Pharmaceutical Congress, Next Generation Dx Summit and Discovery on Target. CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett International, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Knowledge Foundation Bio-IT World Clinical Informatics News and Diagnostics World. www.healthtech.com