Online Certificate in Regulatory Affairs & Compliance for Pharmaceuticals: Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations. This program is designed to help meet the expanding need for regulatory affairs professionals who are able to understand and interpret regulations across the full spectrum of the product lifecycle and who can demonstrate both operational and strategic effectiveness.

Online Certificate in Regulatory Affairs & Compliance for Medical Devices: Pharmaceutical (drug and biologic) and medical device companies today are challenged with a stringent and continually evolving regulatory environment, together with changing technologies and global economic considerations. This program is designed to help meet the expanding need for regulatory affairs professionals who are able to understand and interpret regulations across the full spectrum of the product lifecycle and who can demonstrate both operational and strategic effectiveness.

The Certificate in Financial Services Compliance provides the opportunity for lawyers and non-lawyers to take financial institution law courses offered by the School of Law’s Graduate Program in Banking & Financial Law, the oldest banking LLM program in the country. The 12-credit certificate program is taken online and can be completed in two to four consecutive semesters. The program is open for enrollment in the fall and spring semesters for part-time students. Eight credits, consisting of new courses developed specifically for the certificate program, deal with the history, structure, characteristics, and components of financial institution compliance. The remaining 4 credits may be selected from qualifying courses in the LLM in Banking & Financial Law program curriculum: Banking Structure and Regulation, Pooled Funds and Investor Protection, Governance, Risk Management & Compliance Programs, and Consumer Financial Services.

This course provides students with a detailed understanding of documentary, and regulatory requirements and recommendations for U. S. Export documentation for export transactions and related activities including export licenses/applications and required supporting forms, certifications and other information, export shipping, item classification, customer screening and required recordkeeping.

This three-week course explores the topic of dual-use commodities licensing of US exports and related concerns and issues. With the knowledge gained in this course, students will be able to identify, critically evaluate and assess potential dual-usage items within the export compliance arena to determine the proper licensing procedures.

This orientation course takes a systems approach in examining the role of the Empowered Official (EO). This course will help individuals develop a general understanding of the diverse duties and responsibilities of the practicing EO in overseeing and maintaining integrated trade compliance in an organization that must meet rigid US Government (USG) regulatory requirements.

This course assists those preparing for the U.S. Customs Brokers Examination gain the practical knowledge and understanding necessary to pass the Customs Broker written examination. This course provides a detailed examination of the United States Customs Regulations (Code of Federal Regulations Title 19) as required for successful completion of the Customs Brokers Test.

This course examines the current Export Administration Regulations (EAR), enforced by the Bureau of Industry and Security of the U.S. Department of Commerce. It is taught from the perspective of the practicing professional who needs to know, understand and use this knowledge on a regular basis.

This course examines the U.S. Government’s International Traffic in Arms Regulations’ Exemptions. It provides an in-depth understanding of all the defined Exemptions, their legal usage and applicability. This course examines each allowed Exemption in context of its limited usage, requirements and associated concerns as stipulated under the current Code of Federal Regulations (22 CFR 12-130).

This course examines Duty Drawback regulations, practices and procedures as governed by the US Customs and Border Protection’s regulations (CBP), CFR Title 19 Chapter I :PART 191 – DRAWBACK (§§ 191.0 – 191.195) It also explores the use of ACE and other elements as they relate to duty drawbacks.

This advanced course examines the concept of “Deemed Exports” as transfers made within the United States that are subject to export controls. The Export Administration Regulations and International Traffic in Arms Regulations are both considered.

This orientation to encryption controls takes a systems approach to the topic. It was designed to help individuals develop a general practical working understanding of the licensing requirements, classification issues and exceptions allowed.

This course examines the development and submission of Technical Assistance Agreements (TAAs), Manufacturing License Agreements (MLAs), and Warehousing and Distribution Agreements (WDAs) as required under the International Traffic in Arms Regulations (22 CFR 120-130) as administered by the U.S. State Department, Directorate of Defense Trade Controls (DDTC).

This course explores in detail the regulations of the U.S. Treasury’s Office of Foreign Assets Control (OFAC). The student will study the structure of OFAC regulations and their foundation in law. Also included is an exploration of: Country-based and list-based Sanctions, Specially Designated Nations, Licenses, Reporting, and Recordkeeping.