Course Content

Please note that this program is a study-at-your-pace program because most students are busy professionals and getting everyone on a call at the same time is not practicable. As such, there are no scheduled LIVE classes in the program.

However, there may be occasional LIVE classes or group discussions as the case may be and you will be notified as soon as possible.

Also, note that a few classes like Class 1. Class 4 and Class 6 have additional review classes/videos. So be sure to check back on the Wednesday following the Saturday that the class held for the review class.

Finally, Class One seems to start abruptly but note that you didn’t miss anything. Dr. Layo was just getting introductions from students in class and the main content had not yet started.

Welcome to the Pharmacovigilance Made Easy course.

In today’s class, we will delve into the Grand Scheme of Pharmacovigilance. What exactly is the Big Idea behind this field?

Some of the things we will discuss include; the different phases of clinical trials, the various stakeholders involved in the process, some requisite aggregate reports and how to author them and much more…

Please listen thoroughly, go through your assignments and get back with any questions.

Download Slide Here

1. Describe what you understand by Pharmacovigilance.
2. List out the differences between AE’s and ADR’s (their full names, their individual meaning and their differences). What is another name for AE?
3. There’s a physician on site who is responsible for Clinical trials. His words carry weight, what’s the name of his office/function?
4. Our safety database is called what?
5. Where is patients’ information recorded into when they go to the clinical trial site?
6. List the documents we author in CT phase 1 and describe what each document is.
   Which is an annual one and why is it annual?
7. What’s the name of the application we file at the end of toxicology studies when we want to apply to the agency for permission to go ahead with our CT?
8. Where does the whole process of Pharmacovigilance start and where does it end?
9. Toxicology studies is the same thing as what?
10. Which function uploads adverse events into the safety database?
11. What section of the IB is most important to us as safety physicians or clinical scientists and why?
12. Difference between the AE’s in the Risk profile and the ones in the IB is what?
13. What are ICSR’s (full meaning and what they are)

Answer these questions in a text or voice note and send to Dr, Layo on WhatsApp 

Download the Glossary Here

In today’s class, we take a deeper dive into the Pharmacovigilance Grand Scheme as we look at Phase 2 clinical trials.

Download Slide Here

1) What is the goal of Phase 2 Clinical Trials.

2) Describe the process by which companies find the right dosage for their products in Phase 2 Clinical Trials.

3) What is the RSI? Describe it.

4) Difference between the roles of the Clinical Team and the Safety Team in Phase 2 Clinical Trials.

5) What does the word “Core” mean when referring to documents in our job?

6) Which documents are authored in Phase 2 Clinical Trials that are not listed in Phase 1? Describe them.

7) What is the difference between an AE and an ADR and how do AEs become ADRs?

8) What are the criteria for determining that an adverse event is an important identified or important potential risk? Mention at least 3 of them.

9) Differentiate between Important Identified Risks and Important Potential Risks.

Answer these questions in a text or voice note and send to Dr, Layo on WhatsApp 

In today’s class, we take our study of the Pharmacovigilance Grand Scheme further as we look at Signal Detection and Management.

Download Slide Here