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.
OTHER COURSE PARTICIPANTS SAY:
"It's a great course, it keeps its promises regarding the summary and keywords found on Atrium’s website. The presenters are highly engaged and provide interesting points of view."
Katharina Karlsson. Pharmacovigilance Specialist, Viatris A/S
"The course gives you a good overview of signal management, PSUR and RMP which are important tools in PV. It is good to hear the points of view of both the industry and authorities."
Sana Iqbal, Pharmacovigilance Manager, Billev Pharma ApS
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) & Lecturer(s)
- Cecilie Freddie LangeCourse leaderManager, Safety Surveillance Oral Semaglutide
Novo Nordisk A/S - Marianne Hald ClemmensenCourse leaderSektionsleder, Lægemiddelovervågning EU
Lægemiddelstyrelsen
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 deadline15 May 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(s)
Novo Nordisk A/S
Lægemiddelstyrelsen
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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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