Module 5
Summary
This course will help you understand the preclinical and clinical aspects of pharmacovigilance, including preclinical safety studies. You will also learn about decisions for safety margins and first-dose-in-man, safety principles in phase I, II and III studies, and regulations for safety assessments.
After the course, you will be able to analyze the different pre-application tasks related to preparing clinical study protocols, annual safety reports (SUSARs), integrated clinical study reports and scientific advice in relation to the preparation of clinical trial applications (e.g. endpoints, statistical power, safety parameters, etc.) as well as the pre-application tasks related to conducting clinical studies.
The course is offered every 2 years.
Keywords
- Pre-clinical Safety Studies
- Drug Development
- Clinical Safety Studies
- Risk Assessment
- Pharmacovigilance in Clinical Trials
- Drug Safety
- Regulatory Affairs
- Communication with Regulatory Authorities
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Course leader(s) & Lecturers
- Allan Dahl RasmussenCourse leaderDirector, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S - Lise AagaardCourse leaderSenior Legal Advisor (PhD) Council of Bioethics & Nat. Committee on Health Research Ethics
Sundheds- og Ældreministeriet - Mikael ElanderLecturerSenior Toxicologist
Zealand Pharma A/S - Henrik Friberg-JohansenLecturerPrincipal Toxicologist
H. Lundbeck A/S - Morten LaursenLecturer
Novo Nordisk A/S - Karin Sørig HougaardLecturerSenior Research Scientist, Affiliate Professor in Reproductive Toxicology
National Research Centre for the Working Environment - Birgitte SøgaardLecturerChief Scientist
H. Lundbeck A/S - Fida IssaLecturerSafety Surveillance Specialist
Novo Nordisk A/S - James HigginsonLecturer
Y-mAbs Therapeutics A/S - Andrew MakinLecturerCEO
Andrew Makin Preclinical Consulting ApS - Louise OtzenLecturerPrimary Toxicologist
H. Lundbeck A/S - Jørgen SchützsackLecturerAssociate Director, Toxicology
LEO Pharma A/S - Dorte JarmarkLecturerSenior Event Adjudication Professional
Novo Nordisk A/S - Josephine RasmussenLecturerSafety Surveillance Specialist
Novo Nordisk A/S
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
- Why preclinical safety studies are done and what preclinical data can be used for in safety assessments
- The rationale behind dose selection for first-dose-in-man trials and the reasoning behind decisions for safety margins
- The principles of safety monitoring in clinical phase I, II and III studies and regulations for the assessment and monitoring of safety issues in clinical studies
- How pharmacovigilance units can co-operate with regulatory authorities
- How to share knowledge on preclinical and clinical aspects of pharmacovigilance
What your company will get
- A safety and pharmacovigilance professional who understands why preclinical safety studies are done and what preclinical data can be used for in safety assessments
- A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
- A safety and pharmacovigilance professional that can independently analyze and evaluate the steps in regulating drug safety
- A safety and pharmacovigilance professional who can provide valuable input to all other team members working with preclinical and clinical aspects of pharmacovigilance
Course calendar
DAY 1
- Welcome and introduction
PART 1 – Non-clinical studies leading to Phase 1 clinical trials
Overview of the non-clinical development of pharmaceutical compounds
Pathology – the gold standard in the repeat-dose toxicity studies
Genotoxicity – the discipline that covers many areas
Safety pharmacology – addressing unwanted pharmacological effects
Workshop 1 – Findings prior to going into man
Biologics – The same as small molecules?
- Summery of day 1 and introduction to day 2
DAY 2
- Introduction
PART 2 – Non-clinical studies leading from Phase 1 to marketing and beyond.
- Reproductive toxicity – the discipline that was started by terrible findings
Carcinogenicity – a long-term unwanted side effect
Other aspects of toxicological assessment and introduction to the clinical development plan
Workshop 2 – Findings during clinical development
PART 3: Safety monitoring and surveillance in Phase I- III clinical trials
- Safety considerations with respect to FIH
- Exam info, summery of day 2 and introduction to day 3
DAY 3
- Introduction
- Principles of safety in phase III studies
Workshop
- Safety reporting in clinical trials
- Data Monitoring Committee, incl. case study
- Event Adjudication Committee
- Ethical approval of clinical trials
- Kahoot quiz
- Evaluation, feedback and goodbye for now
Registration
Registration deadline8. Nov 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.
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)
H. Lundbeck A/S
Sundheds- og Ældreministeriet
Lecturers
Zealand Pharma A/S
H. Lundbeck A/S
Novo Nordisk A/S
National Research Centre for the Working Environment
H. Lundbeck A/S
Novo Nordisk A/S
Y-mAbs Therapeutics A/S
Andrew Makin Preclinical Consulting ApS
H. Lundbeck A/S
LEO Pharma A/S
Novo Nordisk A/S
Novo Nordisk A/S
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WANT TO KNOW More or need help?
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