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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Biden administration has brought in new policies and personnel to the federal health care team. The FDA remains in the news every day as it exercises its vast responsibilities over drugs and devices. At the same time, the FDA must restore its reputation, show that it has learned from the pandemic, manage some of the most challenging issues and decisions it has ever faced, and be prepared to effect still further changes. These developments mean regulatory professionals need to fully understand what’s happened thus far and to anticipate, understand, and comply with what’s coming in the future. This virtual program will feature presentations and a panel discussion of five experts with decades of experience working for and with FDA, followed by an opportunity for attendees to ask questions. The experts will explain what we have seen in the first six months of the Biden administration and what to expect going forward in regard to new drug and device development and approvals.
Please note that this workshop will not be recorded.
2 September 2021: Member $300.00 | Nonmember $335.00
The speakers will address questions such as:
12:45 PM EST - Attendees logged into the webinar and placed in a virtual waiting room
1:30 - 1:40 PM EST - Welcome & Introduction
1:40 - 2:10 PM EST - Biden Administration White House/HHS/FDA Team: New Personnel, New Policies
2:10 - 3:00 PM EST - Drug and Device Development and Approval
3:00 - 3:10 PM EST - Break
3:10 - 4:30 PM EST - Challenges Facing a New Commissioner
* Agenda is subject to change.
Anyone who is currently working with the FDA and needs better understanding of the Biden's Administration’s FDA.
Wayne Pines is a member of APCO Worldwide’s international advisory council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to US Food and Drug Administration (FDA) leadership for several decades. Pines provides strategic counsel to clients facing crises, or media, legislative, regulatory, or marketing challenges. He served for 10 years in senior positions at FDA, including as chief media spokesman and associate commissioner for public affairs. He has authored or edited a dozen books about FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.
Andrea Chamblee is senior counsel in the Washington, DC, office of Wilson Sonsini Goodrich & Rosati, where her practice primarily focuses on representing FDA-regulated companies, small and large alike, in efficiently navigating local and national regulatory requirements for research, clinical trials, manufacturing, commercializing, advertising, and promotion. She brings unique first-hand experience with the development and application of complex regulatory programs across regulated commodities to counsel clients at all stages of the medical product lifecycle.
Kellie Combs, partner at Ropes & Gray LLP, provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food, and cosmetics manufacturers, as well as hospitals and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She is a partner in the FDA regulatory practice group and is also a co-chair of the firm’s cross-practice digital health initiative. Combs is currently advising a number of clients on issues related to the COVID-19 pandemic, including the deployment of digital health and telemedicine tools, the manufacture and distribution of personal protective equipment, and the 3D printing of medical devices and components.
Allison Fulton is a partner in the Sheppard Mullin, Washington, DC, office. She is the leader of the life sciences and FDA team. Fulton advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food, and cosmetics companies, in matters relating to the development, manufacture and marketing of products regulated by the US Food and Drug Administration (FDA).
Marc Scheineson is a partner in the Alston & Bird, Washington, DC, office where he heads Alston & Bird’s food and drug law team. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served as the associate commissioner under then- US Food and Drug Administration (FDA) Commissioner David Kessler, for FDA legislative affairs. Scheineson was involved in many of the agency’s innovations, including prescription drug user fees, debarment, medical device amendments, and nutritional labeling.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.