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.
OTHER COURSE PARTICIPANTS SAY:
"I enjoyed the variety of lectures and the great presenters. The whole experience was very rewarding for me. I loved the structure of topics; it was easy and interesting to follow. I made very useful notes, and I am very sure I will use the provided slides in my future work."
Sabina Kujundzic, Pharm. D., Safety Data Associate, H. Lundbeck A/S
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) & Lecturer(s)
- Mette PhilipsenCourse leaderCluster Safety Lead
Pfizer ApS - Søren Troels ChristensenLecturerFarmakovigilanceinspektør
Lægemiddelstyrelsen - Peter EriksenLecturerLead Specialist, Safety Scientist
H. Lundbeck A/S - Morten GaardlykkeLecturerHead of Regulatory Affairs Denmark & Iceland
Pfizer ApS - Mette WikkelsøLecturerPharmacovigilance Officer
Lægemiddelstyrelsen - Mette Stie KallesøeLecturerSenior Principal Professional, Deputy QPPV
LEO Pharma A/S - Line Alleslev LarsenLecturerSenior Pharmacovigilance Specialist
KLIFO A/S - Laila TrolleLecturerPrinciple Safety Advisor
LEO Pharma A/S - Kishore SahaLecturerPV Director
Zealand Pharma A/S - Jeannett DimsitsLecturerPartner
InnoStrat ApS - Jannik NielsenLecturerSenior Safety Surveillance Adviser, Global Safety
Novo Nordisk A/S - Helle von der Recke-HeiselLecturerDirector Drug Safety, Pharmacosmos
Pharmacosmos A/S - Claudia Pierleoni-NielsenLecturerSenior Director, Global Drug Safety & PV
Genmab A/S - Betina Østergaard EriksenLecturerVice President Safety Surveillance
Novo Nordisk A/S - Berit Nautrup AndersenLecturerLead Specialist - QMS, Training and PV Intelligence
H. Lundbeck A/S
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 deadline30 May 2023
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 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
Examination
There is no examination for this course.
Course leader(s)
Pfizer ApS
Lecturer(s)
Lægemiddelstyrelsen
H. Lundbeck A/S
Pfizer ApS
Lægemiddelstyrelsen
LEO Pharma A/S
KLIFO A/S
LEO Pharma A/S
Zealand Pharma A/S
InnoStrat ApS
Novo Nordisk A/S
Pharmacosmos A/S
Genmab A/S
Novo Nordisk A/S
H. Lundbeck A/S
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