Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More

March 5–6, 2024           Virtual Course

Overview

Explore the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A is provided.

Agenda Highlights

  • Regulatory processes for biologics
  • Review and approval process
  • Regulation of biological/drug development
  • Biologics License Application (BLA)
  • Biosimilar biologic products
  • Post-approval safety issues
  • Regulation of biological manufacturing
  • Advertising and promotion requirements
  • Enforcement tools and procedures
  • Changes to the statutory framework for regenerative medicine

Statutes Covered

  • The 1902 Biologics Act
  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Public Health Service Act of 1944 (PHSA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Prescription Drug User Fee Act and Biosimilars User Fee Act
  • 21st Century Cures Act

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Register

$1499

Members

$1899

Non-Members

Industry

$1499

Members

$1899

Non-Members

Government
& Association

$1099

Members

$1299

Non-Members

Public/Patient Org
& Academic

$1099

Members

$1299

Non-Members

Student

Free

Members

$1299

Non-Members

Add This Must-Have Reference to Your Registration Purchase

Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.