Regulatory Compliance: Government Regulations

Learn more about worldwide regulatory bodies, including their structure and operations, legislation, regulations, guidance, and MRA's (i.e., types of regulatory filings, GMP's). Use global compendia and know the requirements of regulating bodies around the world and awareness that differences exist. At the conclusion of this online course, participants will have knowledge of:

  • The role of regulatory bodies worldwide and their structure and operations
  • The role of legislation, regulations, guidance, and MRAs worldwide (for example, types of regulatory filings, GMPs)
  • The use of global compendia
  • The common base in requirements of regulating bodies around the world and awareness that differences exist

Attendance suggested for:

  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s).
Kathleen Elizabeth McCormick
Writer/Publisher
Heathside Information Services Ltd. / ISPE

Dr Kate McCormick is a writer and manufacturing consultant with extensive management experience in the pharmaceutical industry. Kate has worked with multinationals, small and medium sized enterprises, non-governmental organizations (NGOs) and national regulatory authorities in more than 50 countries. Much of her work in the past twenty years has been in Central and Eastern Europe, particularly in Russia and the Former Soviet Union countries. Dr McCormick is the author of 'Quality' (a textbook within the Butterworth Heinemann pharmaceutical engineering series) and 'Manufacturing in the Global Pharmaceuticals Industry' and a former editor of gmp Review. She is an International Education Advisor for ISPE. Dr McCormick has a degree in biochemistry and a doctorate in microbiology, both from London University. She also has a Master in Business Administration from Cranfield University. She is registered as a senior GMP expert for the purposes of EU-funded projects and is eligible to act as a QP under the terms of the EU directive.

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