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:

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
 

• 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.

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	06. Okt 21	18.00
1	Introduction of Pharmacovigilance	Standard Terms And Terminology	1	07. Okt 21	18.00
1	Introduction of Pharmacovigilance	Regulatory Guideline & Laws	1	08. Okt 21	18.00
2	Drug Development Process	Preclinical Phases	1	13. Okt 21	18.00
2	Drug Development Process	Clinical Trial Phases	1	14. Okt 21	18.00
3	The Principles of Pharmacovigilance	Premarketing Pharmacovigilance	1	20. Okt 21	18.00
3	The Principles of Pharmacovigilance	Postmarketing Pharmacovigilance	1	21. Okt 21	18.00
4	Case Processing	Single Case Processing	1	27. Okt 21	18.00
4	Case Processing	MedDRA Dictionary and Coding of Adverse Events	1	28. Okt 21	18.00
4	Case Processing	Single Case and Group Narrative Writing	1	29. Okt 21	18.00
5	Reference Safety Information (RSI)	Investigator Brochure (IB) /Developmental Core Safety Information (DCSI)	1.5	03. Nov 21	18.00
5	Reference Safety Information (RSI)	Core Data Sheet (CDS/local labels)	1.5	04. Nov 21	18.00
6	Adverse Drug Reactions	Individual Case Safety Report (ICSR)	1	10. Nov 21	18.00
6	Adverse Drug Reactions	Case Assessment-Medical review of Cases / Causality assessment / Expedited Reporting	1	11. Nov 21	18.00
6	Adverse Drug Reactions	Case Assessment‐ Practical examples	1	12. Nov 21	18.00
7	Aggregated Safety Reports	DSUR - General Introduction	1	17. Nov 21	18.00
7	Aggregated Safety Reports	DSUR- Template  Report and their Completion	1	18. Nov 21	18.00
8	Aggregated Safety Reports	PSUR/PBRER - General Introduction	1	24. Nov 21	18.00
8	Aggregated Safety Reports	PSUR/PBRER - Template  Report and their Completion	1	25. Nov 21	18.00
9	Signal Management Process	Concept, Input, Periodicity and Materials	1	01. Dez 21	18.00
9	Signal Management Process	Signal Validation, Prioritisation and Evaluation	1.5	02. Dez 21	18.00
9	Signal Management Process	Evaluation of Risk and Recommendations. Process in drug safety report.	1	03. Dez 21	18.00
10	Risk Management Plan (RMPs)	General Introduction	1	08. Dez 21	18.00
10	Risk Management Plan (RMPs)	Template Report and Their Completion	1	09. Dez 21	18.00
11	Pharmacovigilance System Master File (PSMF)	General Introduction	1	15. Dez 21	18.00
11	Pharmacovigilance System Master File (PSMF)	Practical example	1	16. Dez 21	18.00
12	The Big Picture	How It All Fits Together	1.5	22. Dez 21	18.00
12	The Big Picture	Take Home Points and Quiz	1	23. Dez 21	18.00

As of July 2021, subject to change.

Established 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.

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.

What is the maximum number of participants for the course? In order to guarantee high quality content, excellent learning performance and optimal discussion rounds, the course is limited to a maximum of 25 participants.

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 VLE (Virtual Learning Environment). 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 VLE (Virtual Learning Environment) 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.

What can I do with the certificate and the ECTS points?   In order to develop personally and professionally, it is important to keep your knowledge up to date. With this certificate, you can increase your professional opportunities and prove your further education in the field of regulatory affairs in the form of a certificate.

When will I get the certificate?   You will receive the certificate directly from COMD after your homework has been checked and you have passed it.

Does the certificate include an overall grade or grades for the individual modules?   No, on the certificate will be no grades mentioned. Like all awarding organisations, COMD only issue a certificate when achievement has been made. The certificate is accompanied by a transcript indicating the units that have also been achieved. We do not list any marks that have been achieved on a unit by unit basis. COMD will state the course name and completed.