Pharmacovigilance © © Paulista

Post Graduate Award in Pharmacovigilance

  • Flexible study concept with self-study and live webinars
  • Certificate with exam and 10 ECTS

Pharmacovigilance covers the safety and risk issues one must address to ensure patients receive safe drugs. This course will give students a working knowledge of all aspects of drug safety monitoring and risk management, enable them to predict and analyse drug interactions and recognise the implications for prescribing and product license. The student will also be familiar with pharmacovigilance best practice, including monitoring strategies and action plans, and will be fully cognizant of regulatory reporting requirements.

After successfully completing this course, students will be able to:

Understand and critically appraise the principles of pharmacovigilance and landmark cases effecting change to recent drug safety issueExplain key operational drug safety definitionsDemonstrate good pharmacovigilance practice and locate key sources of information and documentationComprehend and discuss global pharmacovigilance Understand drug development and discuss the risks and safety assessment Critically explain the strengths and weakness of pharmacovigilance reporting systemsfuture challenges in drug safety and pharmacovigilance

Learning Aims and Objectives

The aim of this course is to provide education in pharmacovigilance and drug safety and includes  the history and their regulations and guidelines, the key components of the adverse event reporting in the clinical and postmarketing setting, reference safety information documentation, aggregated safety reports and an overview of signal detection and risk management processes.


The key learning objectives are: 

  • Drug safety/pharmacovigilance (PV) regulations and practice, and sources of regulatory guidance
  • Pharmacovigilance processes in the premarketing and postmarketing settings
  • Adverse drug reactions, and process of individual case safety reporting (ICSR), including medical review, case narrative writing, causality assessment and expedited reporting
  • Concept of reference safety information documents and its relevance
  • Aggregated safety reports in the premarketing setting (Development Safety Update Reports- DSUR) and postmarketing setting (Periodic Benefit Risk Evaluation-PBREs).
  • Signal detection processes including signal validation, prioritisation, evaluation, and recommendations
  • Significance of risk management plan, presentation of the report template and its completion

Format & Content

Format:

The course is delivered in 12 weeks over a period of 3 months.

The course is a blended programme of study using a combination of teaching methods which includes:

Webinars (30 hours)

E-learning (12 hours)

Self-directed learning and reflective practice (268 hours)

The hours are an estimate of the time distribution and may vary in between weeks.

Content:

Week 1: Introduction of Pharmacovigilance
Aims:
The aims of this Week are to:
-    Explain the concept of pharmacovigilance (PV), the rationale for modern drug safety/pharmacovigilance (PV) regulation and practice
-    Describe the international policy-making bodies and sources of regulatory guidance
Learning Outcomes:
At the end of the participants will be able to:
-    Understand the concept of pharmacovigilance and drug safety, scope and history
-    Become familiar with the regulatory guidelines and laws that govern pharmacovigilance


Week 2: Drug Development Process
Aims:
The aims of this Week are to:
-    Provide an overview of the drug development process from preclinical drug trials to human clinical trials and the role of pharmacovigilance in the different stages
Learning Outcomes:
At the end of the Week the participants will be able to:
-    Become familiar with all stages of the drug development process from preclinical to clinical phases and the role of pharmacovigilance in the different stages


Week 3 The Principles of Pharmacovigilance
Aims:
The aims of this Week are to:
-    Describe all pharmacovigilance processes in premarketing and postmarketing setting, and areas of the pharmaceutical enterprise in which PV makes significant contributions
Learning Outcomes
At the end of the Week the participants will be able to:
-    Understand the pharmacovigilance function in the premarketing and post marketing settings and their differences


Week 4: Case Processing
Aims
The aims of this Week are to:
-    Describe the process of a single case, MedDRA coding of adverse events, and case narrative writing (single case and group narrative)
Learning Outcomes
At the end of the Week the participant will be able to:
-    Describe and understand the process of a single case report and how adverse events are coded 
-    Understand the importance of a case narrative and their challenges


Week 5: Reference Safety Information (RSI)
Aims
The aims of this Week are to:
-    Describe the reference safety information documents including the IB (Investigator Brochure) and the CDS (Core Data Sheet) and local labels.
-    Explain how expectedness is being assessed
-    Illustrate the importance of the RSI
Learning Outcomes
At the end of the Week the participant will be able to:
-    Become familiar with the concept of safety reference information, understand the different document types and when to make use of them
-    Understand the importance of the RSI in the pharmacovigilance context


Week 6:  Adverse Drug Reactions
Aims
The aims of this Week are to:
-    Define adverse drug reactions and individual case safety report, medical review, causality assessment and expedited reporting
-    Explain the difference between adverse drug event v adverse drug reaction
Learning Outcomes
At the end of the Week the participant will be able to:
-    Understand the concept of drug adverse reaction and apply rules to safety reporting (single case reports) based on theory and practical examples 
-    Understand the difference between adverse drug event v adverse drug reaction


Week 7: Aggregated Safety Reports I
Aims
The aims of this Week are to:
-    Provide an overview of the Developmental Safety Update Report (DSUR), aim and objectives, presentation of the report template and their completion
Learning Outcomes
At the end of the Week the participant will be able to:
-    Understand and become familiar with the concept of DSUR (aggregated safety report), its purpose and content 


Week 8: Aggregated Safety Reports II
Aims
The aims of this Week are to:
-    Provide an overview of the Periodic Benefit-Risk Evaluation Report (PBRER), aim and objectives, presentation of the report template and their completion
Learning Outcomes
At the end of the Week the participant will be able to:
-    Understand and become familiar with the concept of PBRE (aggregated safety reports), its purpose and content
 

Week 9:  Signal Management Process I
Aims
The aims of this Week are to:
-    Provide an overview of all activities related to the signal detection activity, including signal validation, prioritisation, evaluation, and recommendations
-    Tracking and documentation of signal detection activities.
Learning Outcomes
At the end of the Week the participant will be able to:
-    Describe all signal detection activities from identification of a signal to evaluation and final recommendations
-    Determine whether a signal represents a risk which may warrant further assessment, communication, or other risk minimization actions in accordance with the medical importance of the issues


Week 10:  Signal Management Process II
Aims
The aims of this Week are to:
-    Discuss practical examples of signal management.
-    Document a signal investigation as a drug safety report
Learning Outcomes
At the end of the Week the participant will be able to:
-    Understand the signal detection process from a practical example, and the concept of drug safety report as a documentation tool


Week 11:  Risk Management Plan (RMP)
Aims
The aims of this Week are to:
-    Provide an overview of the risk management plan aims and goals, presentation of the report template and its completion. 
-    Provide an understanding on how important risks of therapeutic drugs are to be minimized and/or further characterized
Learning Outcomes
At the end of the Week the participant will be able to:
-    Understand and become familiar with the concept of risk management plan, how to produce and update one, and which planning steps should be taken and why


Week 12: The Big Picture
Aims and Learning Outcomes
-    Review key points of pharmacovigilance, and conclusion.
Quiz and feedback
 

Learning Outcomes

  • On successful completion of this course a student will be expected to be able to:
  • Understand the basic aspects of pharmacovigilance and drug safety, scope and history, and the regulatory guidelines and laws that govern them.
  • Understand the pharmacovigilance function in the premarketing and post marketing settings and their differences.
  • Describe and understand the concept of adverse drug reaction, the process of a single case report, and how adverse events are coded.
  • Become familiar with the concept of safety reference information, understand the different document types and when to make use of them. 
  • Describe the signal detection process from identification of a signal to signal evaluation and final recommendations.
  • Carry out a signal detection analysis from a practical example and understand the concept of a drug safety report as a documentation tool.
  • Demonstrate an understanding of aggregated drug safety reports including DSURs (Development Safety Update Reports) and PBREs (Periodic Benefit Risk Evaluation).
  • Become familiar with the concept of RMP (risk management plan), the report template and the content.

Schedule of the live webinars

All live webinars will be recorded and can be viewed again at any time and as often as you like. So if you have missed one of the webinars it is no problem. If you have any questions you can contact the speaker or simply ask your questions in the next live webinar.

Your benefits of the live webinars
✔ Flexible
✔ Location independent
✔ Participate live or watch the webinar later at your own leisure
✔ Ask your questions directly to the speaker
✔ Discussion with other participants

Week

Topic

Title

Duration (hours)

Date

Time (German time)

1

Introduction of Pharmacovigilance

Overview of Pharmacovigilance

1

16. Mrz 21

17.30

1

Introduction of Pharmacovigilance

Standard Terms And Terminology

1

17. Mrz 21

17.30

1

Introduction of Pharmacovigilance

Regulatory Guideline & Laws

1

18. Mrz 21

17.30

2

Drug Development Process

Preclinical Phases

1

23. Mrz 21

17.30

2

Drug Development Process

Clinical Trial Phases

1

24. Mrz 21

17.30

3

The Principles of Pharmacovigilance

Premarketing Pharmacovigilance

1

30. Mrz 21

17.30

3

The Principles of Pharmacovigilance

Postmarketing Pharmacovigilance

1

31. Mrz 21

17.30

4

Case Processing

Single Case Processing

1

06. Apr 21

17.30

4

Case Processing

MedDRA Dictionary and Coding of
Adverse Events

1

07. Apr 21

17.30

4

Case Processing

Single Case and Group Narrative
Writing

1

08. Apr 21

17.30

5

Reference Safety Information (RSI)

Investigator Brochure (IB) /Developmental Core Safety Information (DCSI)

1.5

13. Apr 21

17.30

5

Reference Safety Information (RSI)

Core Data Sheet (CDS/local labels)

1.5

14. Apr 21

17.30

6

Adverse Drug Reactions

Individual Case Safety Report (ICSR)

1

20. Apr 21

17.30

6

Adverse Drug Reactions

Case Assessment-Medical review of Cases / Causality assessment / Expedited Reporting 

1

21. Apr 21

17.30

6

Adverse Drug Reactions

Case Assessment‐ Practical
examples

1

22. Apr 21

17.30

7

Aggregated Safety Reports

DSUR - General Introduction 

1

27. Apr 21

17.30

7

Aggregated Safety Reports

DSUR- Template  Report and their Completion

1

28. Apr 21

17.30

8

Aggregated Safety Reports

PSUR/PBRER - General Introduction 

1

04. Mai 21

17.30

8

Aggregated Safety Reports

PSUR/PBRER - Template  Report and their Completion

1

05. Mai 21

17.30

9

Signal Management Process

Concept, Input, Periodicity and
Materials

1

11. Mai 21

17.30

9

Signal Management Process

Signal Validation and Prioritisation

1

12. Mai 21

17.30

9

Signal Management Process

Signal Evaluation, Evaluation of Risk
and Recommendations

1.5

13. Mai 21

17.30

10

Signal Management Process

Practical Examples

1

18. Mai 21

17.30

10

Signal Management Process

Drug Safety Report

1

19. Mai 21

17.30

11

Risk Management Plan (RMPs)

General Introduction

1

25. Mai 21

17.30

11

Risk Management Plan (RMPs)

Template Report and Their Completion

1

26. Mai 21

17.30

12

The Big Picture

How It All Fits Together

1.5

01. Jun 21

17.30

12

The Big Picture

Take Home Points and Quiz

1

02. Jun 21

17.30

As of February 2021, subject to change.

Your referent

Yolanda NarainYolanda Narain

Highly motivated and experienced project manager, with a PhD in Biological Sciences, Prince 2 Project Management certification, Team Facilitator and more than 15 years of experience in pharmacovigilance, compliance and project management. Skilled in leading and managing a wide range of national/international cross-functional projects and teams, ensuring compliance, and an appropriate stakeholder management.

Cooperation partner: College of medicine & dentistry, Birmingham (UK)

College of Medicine & Dentistry © College of Medicine & DentistryEstablished in 2018, we are one of the few private education providers offering a wide range of training programmes for the dental team and all healthcare professionals.  Working across a blended learning concept, we aim to reach out to all aspiring individuals to improve their knowledge and skills.  Our collaboration with Ulster University enables us to offer a wide range of career progression opportunities.

FAQ

Frequently Asked Questions

General questions

Is the course limited to a certain period of time? For example, that the course must be completed within 4 months?

Yes, the course is limited to a certain period of time. You have 3 months to participate in weekly webinars and work through the content of the course. After these 3 months, you have an additional 4 weeks to work on the final paper and hand it in to your instructor.
Are there admission requirements for the course or can anyone interested participate?
 

Yes, we have admission requirements: A level 6 degree in Pharmacy, Biomedical science, Medicine or equivalent.

Who is the course designed for?
 

The course is a mixture: for beginners/intermediates.

What is the minimum number of participants for the course?

The minimum number of participants for the course is 5.
When do I have to pay the course price?

You do not have to pay the course price until you have been successfully admitted to the course. After your registration, our cooperation partner COMD will check all admission criteria and conduct the English test, if necessary. Only then, when you have successfully passed everything, you will you receive an invoice from COMD.
Is there also payment by instalments?
 

Yes, payment by instalments is possible. Please contact us in plenty of time if you would like to make use of this option. The instalment payment will then look like this: 30% in advance, 40% after 4 weeks of start, 30% after 8 weeks of start.

What happens after I have submitted my registration?

After you have submitted your registration on our website one of our Springer Campus team will contact you by email. You will get a registration form to fill out and a confirmation of receipt. Please fill in and sign this form and send it back to us, with which we will register you for the course with our cooperation partner CoMD.
How is the course assessment made up?
 

The assessment of whether you have passed the course is made up as follows:

20%: Weekly evaluation based on attendance, active participation and interaction with the speaker and colleagues

40%: Written Essays with 5 Topics/Questions

40%: 3 Case Studies/Practical Exercises

You must achieve 50% to pass the course.

Self-directed learning

Where will the self-directed learning take place?
 

The self-directed learning will take place on Moodle. You will get access by our cooperation partner CoMD.

How it will be structured?
 

For each theme/Topic, a list of relevant scientific publications or papers will be made available to you. This reading material will support the subject discussed in a particular week.

How long can I access the course materials?

You can access the course material at any time during the course. You can also download it so that you can review content even months after the course.
Can the materials be downloaded?
 

Yes, you can download the material.

Will the slides of the power point presentations of the webinar be made available?
 

Yes, the slides will be made available.

Live webinars

How will the webinar be structured? Will there be only one speaker talking about the content or will there also be tasks?
 

They are interactive webinars, with a speaker talking about content and practical exercises.

Who will hold the webinar?
 

The webinar will be held by Dr. Yolanda Narain. For more information about the referent, please see "Your referent" above.

Is every webinar mandatory or is it up to the participant to decide whether or not to participate?

Webinars are mandatory. Students may miss at most 2-3 webinars or about 20%. The webinars are the time for the students to ask questions about the material and see if they really understand the course material.
Where will the webinar start? On which system?
 

All webinars will be imparted using Zoom or Microsoft Teams.

How do I get access to the webinar?
 

An email will be sent to you with the log in details prior to the webinars.

Are the webinars recorded?
 

All live webinars will be recorded and can be viewed again at any time and as often as you like. So if you have missed one of the webinars it is no problem. If you have any questions you can contact the speaker or simply ask your questions in the next live webinar.

Are the live webinars included in the assessment of the course?
 

Yes, 20% of the webinars are included in the overall assessment. There is a weekly evaluation based on attendance, active participation and interaction with the speaker and colleagues.

Exam

Are there intermediate exams between the individual webinars?
 

No, there are no exams between the webinars.

Is there an exam at the end of the course?
 

Yes, this will be in the form of an essay, in which the participants will need to demonstrate understanding.

What’s the format and the procedure of the final exam? How it works?

The final exam will be in the form of an essay and will consist of two parts. For the first part, you will be given 5 questions/topics to write about. The second part consists of 3 case studies/practical exercises. Both parts have a weighting of 40% each and must be handed in together to the lecturer within 4 weeks. The complete paper should not be longer than 15,000 words.
After you have completed it, you will send it back to your referent and receive your assessment within 4 weeks.
When will I receive the tasks for the exam?
 

You will receive the tasks on the last webinar.

How do I hand in the exam then? Do I upload it to Moodle or do I send it directly to the lecturer by email?

Instructions will be provided on the last webinar.
With what percentage do I pass the exam?
 

You must have 50% correct in your essay.

What happens if I fail the exam?
 

CoMD will send you a full feedback with comments and ask you to resubmit the essay. They also will provide support to make you pass the assessment.

Certificate

Does the certificate cost extra?
 

No, the certificate is free of charge.

Will I receive a certificate at the end of the course?

Yes, you will receive a certificate from the College of Medicine and Dentistry after successfully passing the exam. You will also receive 10 ECTS points.

English test

What happens if I don’t meet the English Language (IELTS) level that are published as entry to the course?

Don’t worry COMD can offer you a free diagnostic test with one of our trained English Language assessors. This diagnostic test will give you, and us, an indication of your level of English in the four main components that IELTS tests for:

- Writing
- Reading
- Listening
- Speaking

Are there any additional costs for the English test?
No, there are no costs for you. The test is conducted completely free of charge by the College of Medicine and Dentistry.

How do I take the diagnostic test?
We will arrange for you to take this test with one of our trained providers. The test is conducted online, is confidential and lasts approximately 1 hour.

What is involved?

Step one

Once you tell us you want to take this test you will be introduced to one of our trained assessors. You will be asked to write a short essay of no more than 500 words after reading an article on a related topic which will be provided to you by your dedicated assessors. This will help to ascertain your reading and your writing level. Your will email your written piece in to your assessor who will then review this and give feedback.


Step Two

You will then be invited to online meeting with your dedicated assessors and be asked to answer a series of questions. This will assess your listening and spoken levels.

What happens after I take the test?


The assessor will prepare a short report after they have met with you that also incorporates a review of your written essay. This will give an indication of your English language level and highlight any areas where you have strengths and areas that may need a little more work on. You will receive this report and COMD will also review the report. If the report suggests you have a level that might not support you when attending the course COMD staff will consult with your intention to attend. We may suggest you consider taking the course at a later time once you’ve had chance to review the report and work on any areas highlighted.

Why do I need to take the test?


We want you to get the most out of our courses. To do this we have set a minimum English Language requirement for each of the courses.

What happens if my score is low?


If your test indicates a score that we feel is too low and that it might prevent you from getting the most of the course we will discuss this with you. Our primary objective is to ensure that you not only enjoy the course but can achieve your study goals and objectives for attending and by doing so are able to understand the tutors and benefit from the course content fully.

How many times can I take the test?

We haven’t set a limit on this and can discuss this with you if this arises.

Contact | Information material

For further information about course content, company terms or our in-house seminars please get in touch with us via email or phone. We look forward to hearing from you.

Elina DeutrichElina Deutrich
Springer Campus Marketing
Tel.:  +49 (0) 6221 487 8428
E-mail: elina.deutrich@springernature.com




Registration | Further information about the course


Course: 

Online (live webinars) and self-directed learning


Co-operation partner: 

College of Medicine and Dentistry, Birmingham (UK) 


Duration| Workload: 

12 weeks

310 hours: 30 contact hours (live webinars), 12 hours e-learning and 268 of directed self-learning.


Level:

Level 6 degree in Pharma, Biomed, Medicine or equivalent

English test: The College of Medicine and Dentistry will do an English test (free of charge) internally to the students. The English test will be one hour maximum and will assess the applicant competencies in Speaking, Reading, Writing and Listening. The test will be focused on pharma issues. This will tick the English Language requirements for the course.


Certificate:

Certificate of the College of Medicine and Dentistry (Birmingham) with 10 ECTS


Price:

€ 2200,- (VAT-free)


Start:

Start: 15.03.2021 | Sep 2021

You can still join the course up to 4 weeks after the start date, but you will have to catch up on the material the referent studied up to that point. Simply register for the course via this page.


Booking:

For Companies:
Companies can book this course for their employees at Springer Campus:

Go to registration

For private persons:

This course can also be booked directly by private persons:

Go to registration


Customer recruits customer

You have been or are currently a participant in a Springer Campus Certificate course and know someone in your circle of friends or colleagues who might also be interested in a course? Then you are welcome to recommend us to others! For every successful placement of a participant, you will receive a customer-recruits-customer bonus of EUR 50,-.


AGB