About This Course
This extremely popular course is designed to keep you abreast of the latest developments and trends in the pharmaceutical industry related to regulations, guidances and inspections. Pharmaceutical Law is a key knowledge requisite for the Quality Leader and Technical Professional. A thorough understanding of the laws and legal processes in the US, Europe and beyond is essential in today’s global operating environment.
Regulatory requirements drive many decisions throughout the full product lifecycle – during development, commercialization and supply. Managing changes in compliance with regulatory guidelines and the product license is also often extremely complex. Decision makers must understand this context and think strategically.
What You Will Learn
• The basis of pharmaceutical law – why it exists and what it seeks to achieve. The laws and legislative processes in the USA, EU, Canada, Japan and other key markets
• Initiatives to harmonize and their impact – ICH, PIC/S
• The regulatory framework for APIs, biological products, combination products and Investigational New Drugs
• The role of the Quality Leader and the Qualified Person in Europe
• Latest developments and trends – what are the current hot topics?
Continuing Education Credit
• ACPE Continuing Education Units = 3
• Reference Activity Number = 0616-9999-14-007-L04-P
Luba Skibo and Janeen Skutnik
BY CHECK: Make payable to "NSF Health Sciences LLC" and mail to us at: NSF Health Sciences LLC, 129 South Street, Boston, MA 02111.
BY WIRE TRANSFER
Bank - JP Morgan Chase, New York, NY
ABA Number - 021000021
Account Name - NSF International 790465173
Swift Code - CHASUS33