In this 90 minute webinar you will receive critical information on how global research partnerships are fast becoming a common business model for the biopharmaceutical and medical device industries.
Register today to receive important information on how regulators are responding to globalization and how your company can ensure that it has appropriate controls in place to respond to new risks.
Overview
Manufacturers are responding to increased competition by emphasizing cost-effective R&D models. The expansion of research and development activities into a largely global activity continues to accelerate. The growing prominence and roles of contract research organizations (CROs) has also contributed to a surge in R&D activity in emerging markets, and presents a variety of opportunities and risks. The emergence of an outsourced global R&D model is changing traditional enforcement and compliance approaches, and efforts by the FDA and other regulators to ensure patient safety and prevent corruption of research activities presents new enforcement and compliance challenges.
What you will learn
- What are the FDA’s regulatory and enforcement priorities
- What is the FDA’s jurisdiction ex-US
- The efforts being made for harmonization
- The primary enforcement and compliance issues arising in global trials
- Addressing the risks of outsourcing clinical trials
- Practical tips to identify and mitigate regulatory and compliance risks
Register today and learn what you need to know about how the FDA and other regulators are responding and what new enforcement and compliance challenges you will face.
Who should attend
From Biotech, Pharmaceutical, Medical Device companies
CEOs, CFOs, CMOs
Regulatory
Quality
Clinical Quality Assurance
Risk Management
R&D Operation
Legal Counsel
Compliance
Regulatory Affairs
Your Experts
Dan Kracov heads Arnold & Porter’s FDA and Healthcare practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. Mr. Kracov has over 24 years of experience assisting life sciences companies in the development and implementation of global regulatory compliance programs, managing and responding to manufacturing, bioresearch and pharmacovigilance inspections, addressing complex regulatory and compliance challenges, advising on promotion and advertising issues, and responding to civil, criminal and legislative investigations. His capabilities in strategic advice and crisis management have been widely recognized, including by Chambers, Washingtonian magazine, Best Lawyers, and the Legal Times list of top FDA Lawyers.
Vernessa Pollard is a partner in Arnold & Porter’s FDA and Healthcare group, principally focusing on regulatory matters involving FDA and the US Department of Justice (DOJ). She advises companies on regulatory, compliance, enforcement, and legislative matters involving pharmaceuticals, medical devices, cosmetics, food, and medical technology and software. She regularly counsels companies on product approvals, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event reporting, FDA Warning Letters, FDA inspections, recalls, import detentions, and corporate compliance programs. She has represented companies and executives in FDA and DOJ investigations and enforcement matters. The National Law Journal named her one of the 2011 Minority 40 under 40.
