Clinical Trial and Drug Development

 

Professional Certificate (PCert)

OVERVIEW

 

Embark on a comprehensive journey through the intricate world of clinical trials and drug development with our Professional Certificate (PCert) in Clinical Trial and Drug Development. Tailored for professionals in the pharmaceutical and healthcare sectors, as well as researchers and students interested in understanding the intricacies of bringing new therapeutic agents to market, this course offers an in-depth exploration of the processes and regulations associated with clinical trials. This course will provide you the basic knowledge of different stages of the drug development process, including how drugs are discovered, tested, and turned into suitable medicine. You’ll also learn about clinical trials and the regulatory assessments, that medicine must undergo before being released to patients.

 

In the first two modules, you’ll develop your core scientific and experimental skills across the breadth of drug development including clinical trials, the life cycle of a medicine, and quality control. In the last two modules, you will learn about drug delivery and the latest tools in drug development. You will also have the opportunity to use your skills and knowledge to work on a final project. This will allow you to develop your skills further in clinical trials and drug development.

KEY FACTS

 

Start Date: 31 May 2024

Duration: 1 month (4 weeks)

Delivery: Online

Workload: 4-6 hours per week

Fees: £159

Registration: Register here

Contact: Elisa Hampson admin@camcid.org

PROGRAMME OUTCOMES

 

  • Develop a comprehensive understanding of the drug development process
  • Gain insights into the distinct phases of clinical trials, including their objectives, methodologies, and regulatory requirements
  • Navigate the complex regulatory landscape governing clinical trials
  • Stay informed about emerging trends in clinical trial design, technology integration, and the use of real-world evidence, anticipating the future directions of drug development

PROGRAMME CONTENT

 

The online distance-learning delivery of the course will provide opportunities to receive expertise from the Cambridge Centre for Innovation and Development (CamCID) researchers, material from our partners, and guest lectures.

 

  • Module 1: Fundamentals of the clinical trial: Explore the basics of clinical trials and drug development including processes. Gain a clear understanding of what clinical trials are and their crucial role in advancing medical knowledge and healthcare practices. Explore the distinct phases of clinical trials, from early exploratory studies to late-phase trials, and understand the different phases of a clinical trial. Get an understanding of the objectives and methodologies at each stage.

 

  • Module 2: The life cycle of medicines: Gain a foundational understanding of the drug development process, from the initial stages of discovery to post-market surveillance. Understand strategies for the lifecycle management of pharmaceutical products and the introduction of generic drugs into the market. Understand the life cycle of medicine development in detail including how are medicines evaluated and an overview of pharmaceutical validation.

 

  • Module 3: Drug delivery and quality assurance: Explore the essential regulatory sciences and drug delivery processes. Learn the guidelines for quality assurance in multicenter trials and ensure trial validity by data quality assurance. Navigate the regulatory landscape governing drug delivery systems, understanding the requirements set by regulatory authorities for approval and market authorization. Explore the roles of regulatory affairs professionals in ensuring compliance.

 

  • Module 4: Developments in clinical trials and drug development: Explore the latest technological development and analytical methods used in drug development including 3D printing in pharmaceutical applications, advances in therapeutic protein drug development, and next-generation human skin constructs for drug development.

Entry Requirements

 

  • This course starts with a beginner level and progresses towards the mid-levels. However, prior pharmacology knowledge is NOT required.
  • This course is designed for all levels of students (Undergraduate students, Master's degree students, or Ph.D.).
  • All our online courses are taught in English. Therefore, you must have good English language skills.

Certificate of Completion

 

After completing all the modules of this programme, you will be provided with an e-certificate of completion at Cambridge Centre for Innovation and Development (CamCID).

Design AND Delivery

 

This online programme is delivered on our virtual learning platform (Moodle). The programme is self-paced and it can be completed on your schedule within programme's duration. The programme includes recorded lectures, templates, learning material, ebooks, and research-based tasks. It is designed by the CamCID Research Team and Guest Lecturers (faculty members from international universities).

May include additional material from our partners.

Fees and Funding

 

UK and International: £159 (including electronic certificate).