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

More information


Topics covered in the course:
•    Historical aspects and evolution of drug safety
•    Safety of Drugs
•    Risk assessment and risk management
•    Absorption, distribution, metabolism and excretion (ADME) 
•    Device safety 
•    Collecting and reporting drug safety information
•    Audit and inspection
•    Pharmacovigilance planning
•    Regulatory requirements and legislations in the EU and MENSA
•    Future challenges in drug safety and pharmacovigilance

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

Theme

Title

Duration (hours)

Date

Time (German time)

1

Introduction of Pharmacovigilance

Overview of Pharmacovigilance

1

16. Feb 21

17.30

1

Introduction of Pharmacovigilance

Standard Terms And Terminology

1

17. Feb 21

17.30

1

Introduction of Pharmacovigilance

Regulatory Guideline & Laws

1

18. Feb 21

17.30

2

Drug Development Process

Preclinical Phases

1

23. Feb 21

17.30

2

Drug Development Process

Clinical Trial Phases

1

24. Feb 21

17.30

3

The Principles of Pharmacovigilance

Premarketing Pharmacovigilance

1

02. Mrz 21

17.30

3

The Principles of Pharmacovigilance

Postmarketing Pharmacovigilance

1

03. Mrz 21

17.30

4

Case Processing

Single Case Processing

1

09. Mrz 21

17.30

4

Case Processing

MedDRA Dictionary and Coding of
Adverse Events

1

10. Mrz 21

17.30

4

Case Processing

Single Case and Group Narrative
Writing

1

11. Mrz 21

17.30

5

Reference Safety Information (RSI)

Investigator Brochure (IB)
/Developmental Core Safety

1.5

16. Mrz 21

17.30

5

Reference Safety Information (RSI)

Core Data Sheet (CDS/local labels)

1.5

17. Mrz 21

17.30

6

Adverse Drug Reactions

Individual Case Safety Report (ICSR)

1

23. Mrz 21

17.30

6

Adverse Drug Reactions

Case Assessment‐Medical review of
Cases / Causality assessment /

1

24. Mrz 21

17.30

6

Adverse Drug Reactions

Case Assessment‐ Practical
examples

1

25. Mrz 21

17.30

7

Aggregated Safety Reports

DSUR - General Introduction 

1

30. Mrz 21

17.30

7

Aggregated Safety Reports

DSUR- Template  Report and their Completion

1

31. Mrz 21

17.30

8

Aggregated Safety Reports

PSUR/PBRER - General Introduction 

1

06. Apr 21

17.30

8

Aggregated Safety Reports

PSUR/PBRER - Template  Report and their Completion

1

07. Apr 21

17.30

9

Signal Management Process

Concept, Input, Periodicity and
Materials

1

13. Apr 21

17.30

9

Signal Management Process

Signal Validation and Prioritisation

1

14. Apr 21

17.30

9

Signal Management Process

Signal Evaluation, Evaluation of Risk
and Recommendations

1.5

15. Apr 21

17.30

10

Signal Management Process

Practical Examples

1

20. Apr 21

17.30

10

Signal Management Process

Drug Safety Report

1

21. Apr 21

17.30

11

Risk Management Plan (RMPs)

General Introduction

1

27. Apr 21

17.30

11

Risk Management Plan (RMPs)

Template Report and Their
Completion

1

28. Apr 21

17.30

12

The Big Picture

How It All Fits Together

1.5

04. May 21

17.30

12

The Big Picture

Take Home Points and Quiz

1

05. May 21

17.30

As of January 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.

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

300 hours: 30 contact hours (live webinars) and 270 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:

€ 2.200,- (VAT-free)


Start:

Start: 16. February 2021 (Registration deadline: 09. February 2021) | 14th May 2021

If you would still like to join after the application deadline, simply contact us and we will check whether you can still join the course.


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