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PharScite in Conjunction with CfPA Presents:
Generic Drugs: Approvals, Patents and Exclusivities

April 18-19, 2020, Bangkok, Thailand

When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), it enabled the pharmaceutical industry to seek approval via an ANDA of generic versions of the vast majority of drugs approved by FDA since 1962. New, complex requirements were imposed on persons seeking FDA approval of these generic drugs. Congress also created incentives to encourage development of new branded products, including extended patent protection and periods of non-patent market exclusivity, as well as incentives for generic firms to challenge branded patents.
This course will review the basic provisions of the Hatch- Waxman Act; the information and data required for an ANDA; which drugs are eligible for submission under an ANDA and why; the role of patent protection and market exclusivity; pitfalls and pointers in dealing with the FDA review process; and changing pending ANDAs and Drug Master Files (DMFs). Particular attention will be given in the course to product selection, patent terms, certification, content of the ANDA and DMF, Litigation, Inter Parties Review, and Enforcement.

Who Should Attend

This overview course is intended for personnel from generic and brand name drug manufacturers and bulk drug substance suppliers who seek a broad and thorough understanding of the legal, regulatory, and practical aspects of getting approval to market generic drugs including:
• Regulatory Affairs
• Technical/Scientific/Research
• QA/QC
• Management
• Legal/Compliance
• Manufacturing

Learning Objectives

Upon completion of this course, you will be able to:

  • Discuss, Product Selection, Patent Terms, Patents, and the Orange Book
  • Describe the Format and Content of an ANDA and a DMF
  • Explain ANDA Litigation and Inter Parties Review
  • List Common Enforcement Issues that can affect your ability to get approval and market your product.

Course Director

Frederick (Rick) R. Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. Mr. Ball helps generic pharmaceutical companies, biologics manufacturers, medical device manufacturers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball also assists generic manufacturers bring product to market through patent analysis and Hatch-Waxman litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Finally, Mr. Ball helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal. He is admitted to the Massachusetts State Bar, Illinois State Bar, the Seventh Circuit and the U.S. Supreme Court. He is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.

Accreditations/Recertifications For This Course

The Center for Professional Advancement (CfPA) has been approved as an Accredited Provider by the International Association for Continuing Education and Training (IACET), 11130 Sunrise Valley Drive, Suite 350, Reston, VA 20190. In obtaining this approval, CfPA has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. CfPA is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards. CEUs will be awarded for participation in CfPA’s courses at the rate of .1 CEU per contact hour upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment. This course offers a total of 12 contact hours, or 1.2 CEUs.