Clinical Research Course with Cannabis-based Medicines

Strauss-Levy & Co

Program Description

Clinical Research Course with Cannabis-based Medicines

Strauss-Levy & Co

Learn how to produce sufficient clinical evidence through a regulatory compliant, well designed and high-quality clinical trial.

Cannabis-based medicines are “new creatures” in the regulatory Savanna. Have you ever considered their unique and “pioneering” development pathway and how this differs from other drug development pathways? This pioneering road is what our course is all about.


Key Information

  • Delivery: Self-Paced – 10 modules. For the most efficient learning experience, we recommend that you do not exceed more than one module per day.
  • Language: The course is taught in English.
  • Time Limit: The course will be available for 6 months from the day of purchase.


Course description

No matter if you are seeking a pharma-standard approval, or you are merely seeking to validate the clinical attributes of your product, you must still conduct a fully compliant clinical trial and realize that cannabis treatment trials are different from other trials.

This course is a “must have” for companies and investigators who plan clinical research with cannabis-based treatments and wish to perform the most reliable, robust and regulatory compliant clinical trial with valid and undisputable results.

Clinical research with cannabis-based medicines course is a comprehensive overview of the most fundamental elements in clinical development that are directly linked to the very specific nature of Cannabis-based treatment.

The course is compiled of ten (10), focused modules (chapters) that revolve around the Critical concepts for conducting compliant and effective clinical trials with cannabis-based drugs. This includes crucial study design considerations, cannabis drug-related safety aspects, how to choose your indication, critical statistical principles, the legal and regulatory infrastructure worldwide, pharma economical aspects, and much more.


Who is the course for?

This course is a “must have” for companies and investigators who plan clinical research with cannabis-based treatments and wish to perform the most dependable, robust and regulatory compliant clinical trial with valid and undisputable results.


What will you learn?

  • You will learn the current two-dimensional unmet need that exists in the space of Clinical Trials with Cannabis-Based Drugs and understands the efforts that should be made to answer this need.
  • You will be introduced to the legal and regulatory landscape to conduct clinical trials and be able to choose wisely the most suitable location for conducting your clinical trials based on our Territory Matrix Complexity Grade©.
  • You will learn how to choose your target indication (when possible) while realizing how it influences the complexity of your trial.
  • You will learn how to design a trial that will generate valid and dependable results that conforms to quality and regulatory requirements while taking into account specific trial design options that are more suitable for cannabis-based drug trials.
  • You will be introduced to a step-by-step guide on how to approach the initial steps of design while realizing the most common design mistakes that companies do.
  • You will acquire a tool-kit that consists of the most critical statistical considerations to assure that your overall statistical plan adheres to appropriate standards and avoids pitfalls in data analysis.
  • You will learn about short and long-term safety considerations that must be incorporated in clinical development including adverse events, contraindications, exclusion of special population, drug interactions and the famous P450 enzymatic system.
  • You will learn to incorporate pharma economical measures in your clinical studies so at the end of your studies you will be able to submit your Value Story to insurers, sick funds, health authorities and governmental institutes for reimbursement and coverage.
  • You will understand the Biochemical Uniformity challenge and learn how to cope with this challenge while applying specific rules to reach the “totality of evidence approach” as dictated by FDA 2016 Botanical Guidance.
  • You will meet the regulatory world that surrounds the clinical trial application and which critical pieces of information are mandatory for such an application.
  • You will also learn about regulatory strategy, scientific advice, and special submission options, including Orphan drug designation, Breakthrough Designation, Fast Track, and Accelerated approvals. Much emphasis will be placed on the Botanical Guidance issued by the FDA in 2016.


No matter if you are seeking a pharma-standard approval, or you are merely seeking to validate the clinical attributes of your product, you must still conduct a fully compliant clinical trial and realize that cannabis treatment trials are different from other trials.

105948_pexels-photo-1466335.jpegYash Lucid / Pexels


Course Modules

  • Lesson #1: Why Clinical Trials with Cannabis-Based Drugs are So Essential?
  • Lesson #2: The Legal and Regulatory Landscape
  • Lesson #3: The Indication Challenge and Impact on Trial Complexity
  • Lesson #4: Critical Trial Design Considerations, Part A
  • Lesson #5: Critical Trial Design Considerations, Part B
  • Lesson #6: Statistical Principles for Trials with Cannabis-Based Drugs
  • Lesson #7: Safety Aspects for Trials with Cannabis-Based Drugs
  • Lesson #8: The Drug Formulation Challenge
  • Lesson #9: Regulatory Aspects
  • Lesson #10: Pharma-Economical Aspects of Cannabis-Based Drugs
This school offers programs in:
  • English


Last updated December 3, 2018
Duration & Price
This course is Online
Start Date
Start date
Oct. 2019
Duration
Duration
6 months
Part time
Full time
Price
Price
1,790 USD
*For non Israeli customers VAT does not apply
Information
Deadline
Locations
Israel - Ezor Tel Aviv, Tel Aviv District
Start date : Oct. 2019
Application deadline Request Info
End date Request Info
Dates
Oct. 2019
Israel - Ezor Tel Aviv, Tel Aviv District
Application deadline Request Info
End date Request Info
Videos

clinical trials with cannabis based drugs