Conduct of Clinical Investigations During the Disruption of the COVID-19 Pandemic
Monday, May 18, 2020 | 10 AM CST
This webinar is forecasted for 90 minutes including Q&A.
Topics to be addressed include:
- The primary focus of the guidance: protection of the safety of all study participants;
- How to best implement the principles set out in the FDA and EU guidance, including new expectations for documentation;
- Challenges in implementing alternative remote monitoring of clinical investigations, as well as control of the study product and its delivery to trial participants;
- Approaches to address protocol deviations and changes;
- Potential ethical challenges, including consent and re-consent;
- Protection of participant and data privacy;
- Contractual relationships between sites and sponsors including force majeure,and covenants to achieve “commercially reasonable efforts” in co-development agreements.
This webinar is available to single attendees for $249.
For teams, three logins are available for $395.
Clinical Quality Assurance
Jack Capers, Jr., Partner, King & Spalding
Jack Capers, a partner in our Mergers & Acquisitions practice, specializes in U.S. and cross-border corporate transactions. Jack’s practice is focused on technology and life sciences companies. H advises these companies on a broad range of corporate transactions including mergers, acquisitions, dispositions, spin-offs and divestitures, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercialization, marketing and supply arrangements. He also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries. In addition, Jack advises boards of directors and board committees on corporate governance, M&A transactions and takeover defenses. A frequent speaker and author, Jack addresses topics in M&A and other corporate matters.
Elisabeth Kohoutek, Senior Associate, King & Spalding
Elisabeth Kohoutek is a senior associate in King & Spalding’s Frankfurt office and a member of the FDA & Life Sciences practice. She advises and represents clients in the medical device, pharmaceutical, cosmetics and food industries on legal aspects in every stage of the life cycle of a product, including product development, labeling, advertising, distribution, compliance, data protection, aspects related to parallel importation, protection against falsified products, recalls, if necessary and end-of-life. Elisabeth advises companies in the fields of European Law, Regulatory Law as well as Unfair Competition Law and represents them before national and European courts and authorities. Another focus of her practice involves Data Privacy Law. Prior to joining King & Spalding Elisabeth was working for the international law firm of Bird & Bird, where she was a member of the Life Sciences and Food & Beverage Sector.
Beverly Lorell, MD, Consultant, King & Spalding
Dr. Beverly Lorell is the Senior Medical and Policy Advisor with the firm’s FDA and Life Science Practice in Washington, D.C. Dr. Lorell specializes in the areas of clinical trial design of studies for drugs, devices and biologics; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries. Dr. Lorell, who was previously Professor of Medicine at Harvard University, has over twenty-five years of experience as a practicing interventional cardiologist and heart failure specialist. She is an internationally recognized clinical and basic science investigator with extensive experience in multicenter clinical trials and preclinical proof-of-concept translational science.
Chris Markus, Partner, King & Spalding
Chris Markus focuses on federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions. Chris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as boards of pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.
Geneviève Michaux, Partner, King & Spalding
Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice. Recognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects. Geneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products.
Heather Sampson, Assistant Professor, Department of Family and Community Medicine
University of Toronto
Heather A. Sampson is an Assistant Professor, Department of Family & Community Medicine at the University of Toronto and is a Chair of Toronto Public Health Research Ethics Board. She is responsible for facilitating an integrated applied clinical research program, including quality improvement, health outcomes measurement and knowledge translation; teaching at the University of Toronto. She also provides education and support for Research Ethics Board (REB) members, researchers, medical residents, medical students, support staff, patients and families.
For More Information, Contact:
Division Director, Life Science Programs
+1 (312) 224-1693