Program Objectives

Over the last few years, regulatory agencies have allocated a number of personnel to handle the increasing drug application cases from local and overseas pharmaceutical companies. The training of professionals in regulatory affairs and policy for the development of medical products, standards, evolving legislation and policies become an urgent need in Hong Kong. Graduates from this program will have the opportunity to work for companies involved in the discovery, testing, manufacture, and marketing of medical products. They can take on regulatory affairs positions at pharmaceutical, biotechnology, medical device, diagnostic and healthcare products companies, and government agencies. Regulatory affairs professionals play a crucial role in bridging internal industry departments with regulatory bodies, from product conceptualization to marketing. It is a vital discipline in the development of pharmaceutical products.

Master of Science (MSc) in Drug Regulatory Affairs and Policy (DRAP) aims to prepare graduates to become lifelong learners and leaders in diverse settings including biotechnology, medical devices, pharmaceuticals, consulting, and liaison with government and regulatory agencies worldwide.

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Learning Outcomes
 

On successful completion of the program, graduates will be able to:

  1. Understand the rationale behind, and basic management practices of, quality control and quality assurance of pharmaceutical product development;
     
  2. Develop a thorough understanding on the relevant laws/regulations and/or regulatory environment of drug registration in China or US market; 
     
  3. Gain professional training in keeping up with the increasing scope and complexity of the governmental regulations;
     
  4. Enhance good personality and communication skills in pharmaceutical regulations and policy;
     
  5. Serve as the top management and become main practitioners of the laws and regulations for pharmaceutical companies and/or government agencies; advising them on the regulatory aspects and climate that would affect their proposed activities; and
     
  6. Ensure that the pharmaceutical companies comply with the regulations of NMPA or FDA drug registration and laws pertaining to their business, and work with central, provincial and local regulatory agencies and personnel on specific issues affecting their business.