Pharmaceutical Law & Policy Certificate of Completion

Pharmaceutical law and policy has been undergoing rapid changes in recent years: Assoc. for Molecular Pathology v Myriad Genetics, FTC v Actavis, IMS v Sorrell and US v Caronia all could have enormous implications for the patenting and marketing of pharmaceuticals. Meanwhile, as health reform transforms the legislative and regulatory health care landscape, the pharmaceutical market has been projected to grow from 10% to 14% of total health care spending by 2020.

The Pharmaceutical Law & Policy Certificate is designed to help you understand and navigate these changes. Our Health Law & Policy Institute and Program on Informational Justice and Intellectual Property have teamed up with expert faculty to offer four intensive courses that focus on the law and policies governing the pharmaceutical industry.

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Tuition and Registration

Course Schedule

Faculty

Full Health Law & Policy Summer Institute Calendar

Program on Informational Justice and Intellectual Property Summer Session

Contact Us

Tuition and Registration

Professionals who are not seeking academic credit can register here.

Certificate registrants can still receive CLE.

Standard Rate
Alumni/NGO Rate
1 Course
$1200
$900
2 Courses
$1950
$1450
3 Courses
$2700
$2000
4 Courses
$3450
$2600
Application Fee
$65
$65

 

 

 

 

 

Group Discounts

  • 3 - 5 registrants: 5%
  • 6 - 9 registrants: 10%
  • 10 + registrants: 15%

Course Schedule

June 17 - 18, 9 am - 5 pm

Pharmaceuticals and the Law: This “bootcamp” style course provides an overview of the legal and policy challenges facing those who work in and regulate the pharmaceutical industry.  It is designed for professionals, including non-lawyers, who are seeking to understand the pharmaceutical industry as a whole, from drug development to drug marketing and payment reform. The course will be taught by Daniel Kracov, who heads Arnold and Porter’s FDA and healthcare practice.    

June 19 - 20, 9 am - 5 pm

Pharmaceutical Patent Protection and Enforcement: For lawyers who want to dive more deeply into the intellectual property challenges of pharmaceutical law, Pharmaceutical Patent Protection and Enforcement will analyze the inevitable conflicts that arise between access and exclusivity and examine how patent counsel guide their clients through a legal and regulatory maze to the promised land of a pharmaceutical, medical device, and biologics. Dickstein Shapiro partners Dipu Doshi and Jon Grossman teach this course with Jeremy Cubert of CTTG.

June 21 – 22, 9 am - 5 pm

Pharmaceutical Regulation and Litigation under Hatch Waxman: Hatch Waxman is the fountainhead for a substantial portion of pharmaceutical litigation and, therefore, a key part of pharmaceutical law. This course will explore the origins of Hatch-Waxman and address various issues that arise litigating these cases, including FDA Orange Book patent listing and delisting, the interplay between patent law and FDA law as it pertains to branded drug exclusivity, settling Hatch-Waxman lawsuits, and the newly enacted counterpart to Hatch-Waxman, the Biologics Price, Competition, and Innovation Act for biological drugs. The course is taught by Sanya Sukduang and Jonathan Davies of Finnegan, Henderson, Farabow, Garrett & Dunner.

Faculty

Contact Us

For more information about the Pharmaceutical Certificate or about other courses in the Health Law & Policy Summer Institute, please contact Matt Pierce by email or at 202-895-4518.

For more information about other courses in the Intellectual Property Summer Session, please contact Meredith Jacob by email or at 202-274-4253.