Course Content

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Welcome and Quick Notice:

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.

Class 1 : The Grand Scheme

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

Class 1 Review and Assignment

  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 

Pharmacovigilance Glossary

Download the Glossary Here

Class 2 - The Grand Scheme Part 2

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

Class 2 Review and Assignment

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 

Class 3 - Signal Management Part 1

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

Class 4: A Revision on Signal Management

Having gone through the Pharmacovigilance Grand Scheme, looking at the different stages of clinical trials, and signal detection amongst other things, today’s class is a recap of the past three lessons to help consolidate your knowledge and establish the information gathered so far.

Please listen and revert.

Download Slide Here

Class Revision on Signal Management

Join Dr Layo and some of her students as they review the signal management process in detail.

Practical Signal Management

Look behind Dr. Layo’s shoulders ans she shares her work computer screen with details of her day-to-day activities on the job.

Class 5:

In today’s class, we take the process of signal detection a step further …

Download Slide Here

Class 6

Listen as Dr. Layo further elucidates on the signal management process and shares other details. Please take care to answer the questions that she poses to the class by pausing and trying to come up with your own answers before you listen to other students or even Dr. Layo’s answers. This will help to test your understanding of the subject matter.

As usual, please feel free to reach out if you have any concerns.

Download Slide Here

Class 6 Review

As we wind the training to a close, here is a quick discussion on signal management before the next signal detection class.

Class 6 Review Questions

Recall that during the Class 6 Review class, Dr Layo mentioned some questions that were in the chat box for those on the LIVE call and asked them to answer 2 of them.

Here are the questions for you and you are expected to answer each of them and send them to her.

Class 6 Review Questions

1) What are SUSARS? Explain everything you know about SUSARS and why they are so important to us?

2) Explain the three different buckets we can group our cases into when reviewing case narratives complete with examples.

3) What are we checking for when doing our signal detection?

4) Explain the two kinds of signal detection.

5) List the different sources of signal detection we could have.

6) What is the signal validation process? Explain?

7) How do you escalate a signal if you detect an index case from your line listing?

Practice Interview Questions

Click Here to download the practice interview questions. Answer them and send them over to Dr. Layo via WhatsApp or by Email.

Class 7

In this class, Dr Layo wraps up the Quantitative Signal Detection and prepares you for the Benefit-Risk Evaluation process.

Download Slide Here

Dr. Layo Emmanuel

Instructor

I’m Dr. Layo Emmanuel, a trained physician with a specialization in obstetrics and gynecology. My journey began in clinical medicine, where I dedicated three years to practice. However, I subsequently transitioned into the pharmaceutical industry, initially starting as a Medical Reviewer. Over time, I’ve climbed the ranks to become a Senior Drug Safety Physician, accumulating a wealth of knowledge along the way. Today, I’m excited to impart the valuable insights I’ve gained from my journey with you.

OTHER MATERIALS

Advanced Study Materials: Download Here

Causality Scale: Download Here