Module 2
Summary
This course will help you understand the basic principles of pharmacovigilance systems and the organisation of a pharmacovigilance department and its interfaces with other departments. You will also learn about the standard operational procedures in a pharmacovigilance department and the use of and access to databases, how to prepare and follow up on audits and inspections, and how to operate in a highly dynamic and changing environment.
The course is offered every 2 years.
Keywords
- Pharmacovigilance Systems
- Interfaces with other departments
- Standard Operative Procedures
- Medical Dictionary for Regulatory Activities (MedDRA)
- Qualified Person for Pharmacovigilance (QPPV)
- Periodic Safety Update Reports (PSURs)
- Pharmacovigilance Agreements
- Inspections and Audits
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Course leader(s) & Lecturers
- Heidi Filtenborg MadsenCourse leaderSenior Specialist, QPPV Office
Lundbeck A/S - Wasim AnwarCourse leaderVice President & Deputy QPPVHead of GS Compliance, Global Safety
Novo Nordisk A/S - Elspeth McintoshLecturerDirector
Castle Pharmacovigilance Limited - Ea HolstLecturerDirector
PharmaIT - Noha KassemLecturerSenior Director
Eli Lilly, United Kingdom - Majken BerghuisLecturerDeputy QPPV
LEO Pharma A/S - Åsa LarssonLecturerMRC QA, Sr. Area Lead, Pharmacovigilance
H. Lundbeck A/S - Karen Møller HolmLecturerMedical Information and Pharmacovigilance Manager, Country Safety Head
Sanofi Danmark - Bina Kramhøft SchackLecturerQPPV, GPV, Business Support
H. LUNDBECK A/S - Berit Nautrup AndersenLecturerDirector, QPPV, Head of Global Safety Standards and Compliance
Leo Pharma A/S
IS THIS COURSE FOR YOU?
Whether you are new to the field or have several years of experience, this course is relevant if you are a pharmacovigilance professional who wants to improve your knowledge and skills.
What you will learn
- The basic principles of pharmacovigilance systems
- The organisation of a pharmacovigilance department and its interfaces with other departments.
- How to analyse and evaluate methods and data in drug safety reporting
- How to evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems
- Best practices in drug safety reporting, including relevant Standard Operating Procedures (SOPs)
What your company will get
- A safety and pharmacovigilance professional who understands the principles of pharmacovigilance systems
- A safety and pharmacovigilance professional who can independently analyse and evaluate methods and data in drug safety reporting
- A safety and pharmacovigilance professional who can analyze and evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems
- An employee who can play an important role in any project team working with pharmacovigilance systems
Course calendar
DAY 1
- Introduction to the Pharmacovigilance Systems
- Master File (PSMF) - structure and management
- Local PSMF
- The organizational structure of the marketing authorisation holder
- Workshop
- Computerised systems and databases
- Quality system - procedural documents
- Pharmacovigilance processes
DAY 2
- Pharmacovigilance system performance
- Quality system - document and record control
- Quality system - training
DAY 3
- Audits and inspections
- Workshop
- Pharmacovigilance agreements
- Annexes
- Qualified Person for Pharmacovigilance (QPPV)
Registration
Registration deadline3. Nov 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)
Lundbeck A/S
Novo Nordisk A/S
Lecturers
Castle Pharmacovigilance Limited
PharmaIT
Eli Lilly, United Kingdom
LEO Pharma A/S
H. Lundbeck A/S
Sanofi Danmark
H. LUNDBECK A/S
Leo Pharma A/S
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