Module 4
Summary
This course will help you understand the different aspects of post-marketing surveillance, risk management planning, post-authorization safety studies, and signal management process tools for signal detection, interpretation and handling of findings.
After the course, you will be able to analyze and interpret signals and findings. You will also know how to use and prepare risk management plans, update Summary of Product Characteristics (SPCs), execute recalls, and manage a product life cycle.
The course is offered every 1 1/2 years.
Keywords
- Pharmacovigilance Legislation and Guidance Documents
- Signal Management
- Periodic Safety Update Report (PSUR) and Risk Management Systems
- Signal Detection
- Crisis Management
- Risk Communication
- Product Life Cycle Management
- New Transparency Tools
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Course leader(s) & Lecturers
- Doris Irene StenverCourse leaderIndependent Pharmacovigilance Adviser
Unique Advice - Janne Malene KampmannCourse leaderGlobal and EU QPPV, Senior Director, Global Pharmacovigilance
Lundbeck Pharma A/S - Željana Margan KoleticLecturerHead of Pharmacovigilance Dept
Agency for Medical Products and Medical Devices (HALMED) - Pernille Grell NørgaardLecturerPrincipal Safety Scientist
H. Lundbeck A/S - Maurizio SessaLecturerAssistant professor
Københavns Universitet - Malene Duedal JensenLecturerSafety Scientist
Lundbeck Pharma A/S - Anita Vibsig Neutzsky-WulffLecturerPharmacovigilance Officer
Lægemiddelstyrelsen - Atheline Major-PedersenLecturerSafety Surveillance Principal Specialist at Global Safety
Novo Nordisk A/S - Jesper HallasLecturerProfessor in Clinical Pharmacology
Univerisity of Copenhagen - Karsten LollikeLecturerDirector
Novo Nordisk A/S - Novo Allé
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 different aspects of post-marketing surveillance
- How to analyze and interpret signals and findings
- How to use and prepare risk management plans, update SPCs, execute recalls and manage a product life cycle
- How to share knowledge in relation to post-marketing surveillance
- How to operate in a dynamic and changing environment
What your company will get
- A safety and pharmacovigilance professional who understands the different aspects of post-marketing surveillance
- A safety and pharmacovigilance professional who can independently analyze and interpret signals and findings
- A safety and pharmacovigilance professional who can provide valuable input to all other team members working with post-marketing surveillance
Course calendar
DAY 1
- Current pharmacovigilance legislative framework and guidelines
- Signal management process from a Marketing
- Authorisation Holder’s (MAH) perspective
- Tools for signal detection
- Signal management process from a regulatory authority’s perspective
- Workshop - Signal detection
DAY 2
- PSUR Guidance
- PSUR handling and assessment
- Risk Management Plans (RMPs)
- Post Authorization Safety Studies (PASS)
- Pharmacoepidemiology in pharmacovigilance
DAY 3
- Workshop - Crisis Management
- Crisis management/Product Recalls
- Executions of a recall
- Effective risk communication
- Impact assessment of pharmacovigilance – the PRAC strategy
Registration
Registration deadline28. Sep 2021
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 takes place online about 4-6 weeks after the course, and you can access it from any location that suits you.
You receive a link with the exam questions via your personal Atrium log-in.
This course is a part of this programme
The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Pharmacovigilance Diploma
Read moreCourse leader(s)
Unique Advice
Lundbeck Pharma A/S
Lecturers
Agency for Medical Products and Medical Devices (HALMED)
H. Lundbeck A/S
Københavns Universitet
Lundbeck Pharma A/S
Lægemiddelstyrelsen
Novo Nordisk A/S
Univerisity of Copenhagen
Novo Nordisk A/S - Novo Allé
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