IRA815 - International Regulatory Affairs and Harmonization

Outline information
Semester
Schools offering this subject
Last revision date 2017-05-29 00:25:03.107
Last review date 2017-07-17 00:16:28.043

Subject Title
International Regulatory Affairs and Harmonization

Subject Description
This subject provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in European countries, Japan and USA are examined as well as the regulations in a selected number of other geographic locations. Specification criteria and tests with drug substances and drug products are compared and the reasons behind regulations and controls are examined.

Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

Appreciate the need for global harmonization  
Describe the ICH (International Conference on Harmonization) and demonstrate a familiarity with the past and current issues being addressed by the ICH and understand the history of the ICH Meetings and Conferences.  
 
Describe the regulatory process of pharmaceutical products in the USA, Europe, Japan and those in major locations.  
Demonstrate a familiarity with specific tests and criteria that are part of ICH guidelines.   
Describe the implementation of Mutual Recognition Agreements (MRA) between countries.  
Understand the differences in the regulatory environment around the world and appreciate the importance of emerging markets in the growth of pharmaceutical marketing and regulatory affairs profession.  
Describe and compare the regulatory process of pharmaceutical products in emerging markets  

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.