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Victoria Sharma
Program Director

Clinical and Regulatory Sciences

The steps involved to bring a drug, biologic or medical device from discovery to market are complex and high-risk, requiring a thorough knowledge of procedures and pitfalls at every stage of the process. Extension courses address all of the essential aspects of these fields—and many courses apply to multiple programs, allowing you to earn credit while you find the curriculum that's right for your career goals. In addition, Extension courses meet the continuing education requirements of key professional organizations.

Clinical Research Conduct and Management involves the design, execution and management of clinical trials. Extension’s courses and certificate offer newcomers a foundation in the field and seasoned biotech and health professionals the opportunity to advance their skills. Courses are offered both in the classroom and online.

Regulatory Affairs personnel ensure that the development of drugs and dossiers for clinical trials and licensure are in accordance with the Food and Drug Administration (FDA), International Conference on Harmonisation (ICH) and regulatory bodies worldwide. Many of Extension’s regulatory affairs courses are offered as two-day intensive seminars.

Quality and Compliance managers ensure that the entire drug development process follows protocols and meets regulations, including Good Pharmaceutical Practice (GXP) principles. Become an expert in the application of regulatory principals to the development, manufacture and marketing of bioscience products.

View all courses in Clinical and Regulatory Sciences, Regulatory Affairs and Quality and Compliance.

Featured Courses

Epidemiology for Clinical Research

Gain a working knowledge of the analytic tools for making health care decisions based on quantitative evidence of the patient and community levels. Learn more.

Introduction to Clinical Research: Clinical Trial Phases and Design

Review the drug development process, principles of good clinical practice, clinical trial phases and design, principal players in clinical research, regulatory strategies, and medical terminology. Learn more.

Principles of Quality and Compliance

Get an introduction to the regulatory authorities whose regulations must be implemented to ensure compliance with the laws governing the biotech industry. Learn more.

Good Manufacturing Practices (GMP): Quality Control (QC) in Quality and Compliance

Gain an understanding of the quality control function and the difference between quality assurance and quality control and the role and function of the QC department. Learn more.

Principles of Regulatory Affairs

Get an introduction to the regulatory authorities whose regulations and requirements must be implemented and met to ensure compliance with the laws governing this industry. Learn more.

Professional Certificate (What is a professional certificate?)

Clinical Research Conduct and Management (EDP 402389) Also Available Online!

Master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations. Learn more.

Specialized Programs of Study (What is a specialized program of study?)

Regulatory Affairs (EDP 402454)

Regulatory affairs personnel are the first-line assurance that company products and documentation are in accordance with regulatory bodies worldwide. This program provides the training to manage these activities. Learn more.

Quality and Compliance for Biotechnology (EDP 402363)

Build a thorough foundation in the skills needed to perform and oversee compliance, regulations and guidelines that govern the research, development, manufacturing and clinical trials processes, as well as the marketing and sales of drugs, biologics and medical devices. Learn more.

Learn more about all of UC Berkeley Extension's professional certificates and specialized programs of study.

Courses of Related Interest

Professional Organizations

UC Berkeley Extension courses meet the continuing education requirements established by the following professional organizations:

Information Sessions

Learn more about Extension—without making a commitment. Come to a free, no-obligation information session to discover how we can help you achieve your goals. Learn more about courses and programs, meet other prospective students, talk to instructors and staff and ask questions.

Enroll in a free information session or call (510) 642-4111 to reserve your space.

Contact

To contact the department office, send an email to science@unex.berkeley.edu or call (510) 642-1062.