The UGA Graduate Certificate is a one-year program, which enhances residency program experiences to foster excellence in clinical training and scholarship. All UGA and UGA-affiliated residencies participate. Upon successful completion of the program, residents will be awarded a Graduate Certificate in Clinical Pharmacy in addition to the residency certificate.

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The Chemistry, Manufacturing, & Controls (CMC) graduate certificate is designed to prepare the student for working in the highly regulated medical product industry in the specialized area of CMC.

Upon completion of the certificate program, students will:

• Be knowledgeable in laws, regulations, and guidelines related to drug approval requirements,
• Know Good Manufacturing Practices (GMP) and Quality by Design (QBD) principles
• Outline the product development process for medical products
• Locate information necessary to their role as CMC professionals
• Describe the pre-approval and approval CMC requirements for new products, including the maintenance of those products after marketing
• Be familiar with the complex interaction between regulatory requirements and development processes for new products
• Be knowledgeable of the key aspects of the manufacturing process as it relates to regulatory review and inspection policies
• Apply established principles of the submission process that regulatory authorities use to evaluate new medical product applications

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Geared toward a wide range of professionals, the Clinical Trials Design & Management Certificate Program provides a foundation for preparing candidates to manage the development and implementation of scientifically valid clinical study designs including monitoring of clinical trials and directing daily clinical trial operations. The interdisciplinary program encompasses critical core competency areas including biostatistics, federal regulations, bioethics and project management as integral parts of drug product development and medical device design validation required for federal regulatory market clearance and initial commercialization. The program plan is ideal for working professionals and consists of 17 semester credit hours, delivered by Internet-based instruction.

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This innovative program prepares the student for working in the highly regulated medical industry in the specialized area of Drug Safety or Pharmacovigilance.

Upon completion of the Drug Safety and Pharmacovigilance certificate program, students will be able to:

• Be knowledgeable in laws, regulations, and guidelines related to drug safety and pharmacovigilance principles
• Outline the product development process for medical products
• Locate information necessary in their role as drug safety and pharmacovigilance professionals
• Describe the pre-approval and approval requirements for the safety of new products, including the maintenance of those products after marketing through pharmacovigilance systems
• Be familiar with the complex interaction between regulatory requirements and development processes for new products.
• Apply established principles of the submission process that regulatory authorities use to evaluate new medical product applications Be familiar with safety signal monitoring and detection technologies

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Due to the rapidly expanding biomedical industries, an increase in the number of Regulatory Sciences professionals is needed to maintain compliance with regulatory policies and procedures for multiple product lines. The Regulatory Sciences Graduate Certificate Program provides a foundational core for individuals who wish to round out their experiences in regulatory sciences or transition into entry level regulatory affairs positions. Specialized and convenient education is crucial for busy professionals to gain and maintain an understanding of the scientific and technical background of new or existing products. The program plan is ideal for working professionals and consists of 14 semester credit hours, delivered by Internet-based instruction.

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The purpose of the certificate program is to prepare the student pharmacist to be able to recognize and take advantage of entrepreneurial opportunities. In this program, students will have the opportunity to develop skills in business, management, and leadership. The program also aims to foster innovation and critical thinking needed to move the profession forward. After completing the program, students should have the knowledge, skills, and abilities needed to implement, maintain, and improve programs in a variety of pharmacy settings.

This program is only open to students enrolled in the Doctor of Pharmacy program.  Students may apply during spring of their second year.

Download the program description and requirements.