Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
The importance of safety concerning pharmaceutical products and medical devices cannot be overemphasized. Hence, it is necessary to evaluate the response of the human body to the presence of a novel drug or device. The First in Human Safety Assessment (FIHSA) is a vital and fundamental part of clinical trials which sees an experimental drug or device making the transition from use in animals or simulations to a human body.
This course takes you on a journey through the historical evolution of the concept of safety from the technological phase to the holistic phase which takes into account technology, humans, and the organization in vie. You will be introduced to the methods of dose determination for FIHSA studies and the role of the International Conference on Harmonization (ICH) guidelines in ensuring that risks are reduced to the barest minimum.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Historical Aspect of First Human in Safety
Lesson 2: Successful Design for First-in-Human Safety Clinical Trials
Lesson 3: First in Human Safety and Drug Development Process
Lesson 4: Dose Estimation in First Human Safety
Lesson 5: Risk Assessment; Evaluation of Risks for First in Human Health and Safety
Lesson 6: Role of ICH in First in Human Safety