Summary
Module 6
This course will help you understand the relationship between pharmacovigilance and the processes of application and registration. We will focus on the areas and phases in drug development processes where the clinical development, registration, and pharmacovigilance units co-operate closely.
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 leaderSenior Specialist, Safety Scientist
H. Lundbeck A/S - Sabine StrausLecturerChair, PRAC
EMA - European Medicines Agency - Nanco HeftingLecturerChief Specialist
H. Lundbeck A/S - Sasha Ann Solow RahbekLecturerPrinciple Medical Writer
LEO Pharma A/S - Jens HeisterbergLecturerVP, Regulatory Policy and Intelligence
Novo Nordisk A/S - Carina RosenkildeLecturerSurveillance Specialist
Novo Nordisk A/S - Delphine SaragoussiLecturer
Evidera
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 analyze 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 analyze 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 trial protocol
- Handling of safety data during a clinical trial
- Clinical study report with specific focus on the safety sections
- Clinical documents in application
- Clinical safety summary
- Clinical overview
- Workshop
Day 2
- Summary of Product Characteristics (SPCs)
- Preparation for meeting with and presenting to regulatory authorities
- Regulatory strategy in clinical development
- The centralized procedure
- Risk Management Plan (RMP)
- Risk-benefit framework
- Post Authorization Safety Studies (PASS)
Registration
Registration deadline17 Oct 2023
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 familiarize 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
Lecturers
EMA - European Medicines Agency
H. Lundbeck A/S
LEO Pharma A/S
Novo Nordisk A/S
Novo Nordisk A/S
Evidera
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Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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