Sponsored Webcast: Understanding Key Components of a Clinical Evaluation

When:  Oct 6, 2021 from 11:00 to 12:00 (ET)

Registration Fee: Complimentary


Description

When building your regulatory strategy for a new or existing product, it’s important to understand regulatory precedent against which to compare your competitor’s approaches and how to optimize your product’s approval and launch.

During this webcast, Linda Bowen MSc, RAC, FRAPS will cover the importance and value of precedent, how you can identify good sources of precedent and how precedent can help you to gain insights to build and optimize regulatory strategies for existing and new products. At the end of the main educational section, attendees will have the opportunity to stay on the call for an additional 15 minutes to watch a case study walk-through examining locating precedent related to Drug Product Approvals. Attendees will also have the opportunity to ask questions relating to the presentation.


This event is brought to you by IQVIA .





Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Learning Objective

At the conclusion of this program, attendees will:

  • Fully grasp the value of precedent
  • Know how to identify good sources of precedent
  • Understand how precedent can help you to gain insights to build and optimize regulatory strategies for existing and new products

Who Should Attend?

  • Regulatory Intelligence professionals
  • Pharmaceutical Regulatory professionals, involved in or leading the development of the Regulatory strategy and plan for new and existing products

Speakers

Linda Bowen, Head of Regulatory Policy and Intelligence, Seagen

Linda Bowen leads the regulatory policy and intelligence function at Seagen Inc. (formerly Seattle Genetics), a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Her team is responsible for monitoring and surveillance of the global regulatory environment and driving effective regulatory intelligence to ensure that Seagen is well positioned to proactively influence and to be prepared for key external regulatory changes. .

Bowen has 38 years of experience in the biopharma industry, predominantly in regulatory affairs (28 years) with a focus on regulatory policy, intelligence and strategy for the last 15 years


Victoria Small, Head of Client Services, IQVIA Regulatory Intelligence, IQVIA

Victoria Small leads the client service team at IQVIA Regulatory Intelligence (Tarius), which is composed of five individuals providing global coverage. The team has more than 20 years of combined experience within the pharmaceutical and medical device industries, and has extensive experience in training and how to incorporate IQVIA Regulatory Intelligence into an organization.

Before joining IQVIA Regulatory Intelligence, Small spent more than 10 years at Alcon, covering regulatory affairs, product surveillance, compliance, and client services.


Sue Plant

Sue Plant, IQVIA Regulatory Intelligence – Offering Director, IQVIA

Sue Plant leads the offering team for IQVIA Regulatory Intelligence (Tarius), responsible for understanding customer needs and ensuring that the offering meets those needs, now and in the future. She has more than 20 years of experience in the life sciences industry, including roles in sales, marketing, client services, consulting and offering development, with experience in medical devices, pharmaceuticals, technology and compliance/regulatory.