Summary
At this course, you will learn the basics about safety and pharmacovigilance in post-marketing surveillance and clinical trials. You will receive a comprehensive introduction to essential terminology and information sources as well as a thorough introduction to why and how clinical trials are performed.
The course also examines regulatory reports such as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR), product safety information and signal detection, interfaces with regulatory departments and with quality assurance about pharmacovigilance audits and inspections, and how to prepare for these.
Keywords
- Danish and European Drug Safety Regulations
- The Danish Health and Medicines Authority
- The Individual Case Report
- Electronic Submission
- MedDRA
- Clinical Trial Directive 2001/20EC
- Non-Interventional Trials
- Risk Management Plans
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Course leader(s) & Lecturers
- Mette PhilipsenCourse leaderCluster Safety Lead
Pfizer ApS - Berit Nautrup AndersenLecturerDirector, QPPV, Head of Global Safety Standards and Compliance
Leo Pharma A/S - Claudia Pierleoni-NielsenLecturerSenior Director, Head of Medical Safety
Lundbeck A/S - Laila TrolleLecturerPrinciple Safety Advisor
LEO Pharma A/S - Mette Stie KallesøeLecturerSenior Principal Professional, Deputy QPPV
LEO Pharma A/S - Jeannett DimsitsLecturerSr. Director
Zealand Pharma A/S - Line Alleslev LarsenLecturerDeputy QPPV
Leo Pharma A/S - Peter EriksenLecturerPharmacovigilance Specialist
H. Lundbeck A/S - Helle von der Recke-HeiselLecturerDirector Drug Safety, Pharmacosmos
Pharmacosmos A/S - Jannik NielsenLecturerSafety Surveillance Speciality, Signal Management & Digital Health
Novo Nordisk A/S - Kishore SahaLecturerPV Director
Zealand Pharma A/S - Morten GaardlykkeLecturerHead of Regulatory Affairs Denmark & Iceland
Pfizer ApS - Betina Østergaard EriksenLecturerVice President Safety Surveillance
Novo Nordisk A/S - Søren Troels ChristensenLecturerFarmakovigilanceinspektør
Lægemiddelstyrelsen - Doris Irene StenverLecturerIndependent Pharmacovigilance Adviser
Unique Advice
IS THIS COURSE FOR YOU?
This course is relevant if you are new to the pharmaceutical industry or work in an affiliate company and wish to obtain a general understanding of safety and pharmacovigilance, incl. risk management plans, crisis management or audits and inspections. You will also benefit from the course, if you are a pharmacovigilance employee collaborating with clinical development colleagues on e.g. adverse event reporting.
What you will learn
- The basic principles and elements of pharmacovigilance
- The essential terminology and information sources
- How to use best practices in drug safety and pharmacovigilance working processes
- How to prepare adverse event reports and the appropriate pharmacovigilance working methods
What your company will get
- A safety and pharmacovigilance professional who understands the basic principles and elements of pharmacovigilance
- A safety and pharmacovigilance professional who can operate in a dynamic and changing environment
- A safety and pharmacovigilance professional who can provide valuable input to all other team members working with drug safety and pharmacovigilance
Course calendar
DAY 1
- Regulations and guidelines
- Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
- System master file
- Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
- Product safety information
- Workshop
DAY 2
- Periodic Safety Update Report (PSUR)
- Clinical development
- Clinical Trials Directive
- Non-interventional studies and post-authorization safety studies
- MedDRA coding
- Workshop
DAY 3
- Development Safety Update Report (DSUR)
- Signal detection
- Crisis management
- Risk management plans
- Inspections
- How to prepare for audits and inspections
Registration
Registration deadline26. Oct 2021
Lersø Parkallé 101
2100 København Ø
DAY 1
- Regulations and guidelines
- Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
- System master file
- Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
- Product safety information
- Workshop
DAY 2
- Periodic Safety Update Report (PSUR)
- Clinical development
- Clinical Trials Directive
- Non-interventional studies and post-authorization safety studies
- MedDRA coding
- Workshop
DAY 3
- Development Safety Update Report (DSUR)
- Signal detection
- Crisis management
- Risk management plans
- Inspections
- How to prepare for audits and inspections
Registration
Registration deadline10. May 2022
Lersø Parkallé 101
2100 København Ø
DAY 1
- Regulations and guidelines
- Qualified Person Responsible for Pharmacovigilance’s (QPPV) role and responsibility
- System master file
- Handling of Individual Case Study Report (ICSR), including licensing partners and pharmacovigilance (PV) agreements
- Product safety information
- Workshop
DAY 2
- Periodic Safety Update Report (PSUR)
- Clinical development
- Clinical Trials Directive
- Non-interventional studies and post-authorization safety studies
- MedDRA coding
- Workshop
DAY 3
- Development Safety Update Report (DSUR)
- Signal detection
- Crisis management
- Risk management plans
- Inspections
- How to prepare for audits and inspections
Registration
Registration deadline25. Oct 2022
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
Examination
There is no examination for this course.
Course leader(s)
Pfizer ApS
Lecturers
Leo Pharma A/S
Lundbeck A/S
LEO Pharma A/S
LEO Pharma A/S
Zealand Pharma A/S
Leo Pharma A/S
H. Lundbeck A/S
Pharmacosmos A/S
Novo Nordisk A/S
Zealand Pharma A/S
Pfizer ApS
Novo Nordisk A/S
Lægemiddelstyrelsen
Unique Advice
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WANT TO KNOW MORE or need help?
Contact Client Manager Ida Salicath at +45 39 15 09 46
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