The FDA has made a commitment in recent years to speeding up drug and device approvals. At the same time, it has ramped up its demands on life sciences companies to improve their post-marketing surveillance of new products to ensure consumer safety. Similar trends are happening in regulatory systems across the world.

This webinar explores the latest regulatory requirements in the post-marketing setting, both in the U.S. and abroad. It will provide details about some of the most recent developments in this area, including a move by the FDA in 2018 to require that companies marketing drug-device combination products report all complaints about safety to the agency.

Topics include:

  • An explanation of the post-marketing requirements that were laid out in the Food and Drug Administration Modernization Act of 1997, as well as an overview of changes and additions that have been made since that time.
  • Real-world examples of how post-marketing requirements caught some companies by surprise, and how they adapted their internal practices to be better prepared for such requirements going forward.
  • A comparison of requirements for post-marketing surveillance from the FDA and key overseas regulatory bodies, including the European Medicines Agency.

Featured Speakers

Moderator: Eric Sagonowsky

Fierce Pharma

Eric Sagonowsky is an editor with FiercePharma and FierceVaccines. He joined the Fierce staff in November 2014 and covers topics such as drug pricing, biosimilars and product liability litigation.

Alexander Roussanov

International Partner
Arnold & Porter

Alexander Roussanov, a former senior legal adviser in the Legal Department of the European Medicines Agency (EMA), focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotion activities, privacy and data protection counseling, and interactions with health care professionals.

Heidi Forster Gertner

Hogan Lovells’ Pharmaceuticals and Biotechnology regulatory practice

Heidi Forster Gertner is a partner in Hogan Lovells’ Pharmaceuticals and Biotechnology regulatory practice based in Washington, D.C. She uses her 13 years of experience as a former lawyer in the FDA’s Office of Chief Counsel to help her pharmaceutical clients resolve drug regulatory issues and foster positive relationships with the agency. Gertner began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships, one at the Cleveland Clinic Foundation, and another at the National Institutes of Health.

Jodi Scott

Hogan Lovells’ Medical Device and Technology regulatory practice

Jodi Scott is a partner in Hogan Lovells’ Medical Device and Technology regulatory practice based in Denver. A former in-house FDA lawyer for the world’s largest medical device manufacturer, she assists her medical device industry clients through a range of complex regulatory and compliance issues including Medical Device Reporting (MDRs), regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, and developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses).

Trygve Anderson, RPh

VP, Commercial - Pharmacy Informatics Team
Elsevier Clinical Solutions

As Vice President, Commercial - Pharmacy with Elsevier, Trygve Anderson provides strategic direction and oversight to increase market penetration and drive revenue growth within the commercial pharmacy division. Mr. Anderson is committed to building success through collaboration with stakeholders in commercial, marketing, product and technology. In his leadership role he is known for effective go-to market strategies and fostering innovation — to deliver high-value pharmacy solutions to customers.

Mr. Anderson also provides insight to support the sales team and partners with customers to develop a visionary approach to continually improve Elsevier’s drug information products.

Previously Mr. Anderson was Vice President, Retail Pharmacy Solutions directing the development of Elsevier’s drug information products and clinical editorial tools and served as Director of Integrated Product Sales for several years.

Mr. Anderson received his Bachelor of Science degree in Pharmacy from Purdue University School of Pharmacy and Pharmaceutical Sciences. Mr. Anderson brings 30 plus years of experience in health care automation with a primary focus on drug information and decisions support.

Additionally, Mr. Anderson has served in a wide range of leadership roles with Siemens Medical Systems USA (formerly Shared Medical Systems) focusing on the development, installation and support of clinical and pharmacy systems software. Mr. Anderson’s professional background includes practicing pharmacy in both hospital and nuclear pharmacy settings.

Now available on-demand