Summary
Module 6
This two-day course provides a comprehensive overview of how safety data supports successful drug registration.
You’ll explore how safety data is generated, analysed, and presented in key regulatory documents such as the Clinical Summary of Safety, Clinical Overview, Risk Management Plan, and label.
The course highlights the importance of cross-functional collaboration between the safety department, clinical development, and regulatory affairs.
You will gain insights into regulatory expectations for initial marketing authorisation applications and learn from industry and regulatory experts.
Whether you're directly involved in regulatory applications or want to better understand the role of safety in drug development, this course will enhance your ability to contribute effectively to interdisciplinary teams.
Keywords
- Clinical Trial Protocol
- Clinical Study Report
- Summary of Clinical Safety and Clinical Overview
- Post Authorization Safety Studies (PASS)
- Summary of Product Characteristics (SPCs)
- Risk Management Plan
- Evaluation of Applications for New Medicinal Products by Authorities
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Course leader & lecturers
- Bodil Svanholm FoghCourse leaderLead Specialist, Safety Lead
H. Lundbeck A/S
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Is this course for you?
Whether you are new to the field or have several years of experience, this programme is relevant if you are a pharmacovigilance professional who wants to improve your knowledge and skills.
What you will learn
- The relationship between pre-marketing clinical safety and the processes of application and registration
- How to analyse the different pre-application tasks related to clinical safety and turn them into an application for marketing authorisation
- The application’s implications for post-authorisation pharmacovigilance
What your company will get
- A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
- A safety and pharmacovigilance professional that can independently analyse the different pre-application tasks related to pharmacovigilance
- An employee who can play an important role in any interdisciplinary project team
- An employee who can provide valuable input on how to improve cooperation between the clinical development, registration and pharmacovigilance units
Course calendar
Day 1
- Clinical development plan
- Clinical trial reports with special focus on the safety sections
- Risk Management Plan
- Clinical Safety Summary and Clinical Overview
- Evaluation of safety data from the authorities' perspective
Day 2
- Safety data in labeling / Summary of Product Characteristics
- Pharmacovigilance Risk Assessment Committee's (PRAC's) function
- Risk-Benefit Framework
- Post Authorization Safety Studies (PASS)
Registration
Registration deadline10 Nov 2025
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarise yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in drug safety or pharmacovigilance, or other equivalent qualifications. We consider all applications upon registration
If you do not fulfill the requirements, you can still apply for the course if you have suitable experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in drug safety or pharmacovigilance. We consider applicants on a case-by-case basis.
Examination
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
This course is a part of a diploma
The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Diploma in Pharmacovigilance.
Read moreCourse leader
H. Lundbeck A/S
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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