SUMMARY
This course gives you a general overview and understanding of why clinical drug research is conducted the way it is today, how drugs are developed, how to monitor adverse drug reactions (ADRs), what monitoring during clinical trials entails and who is responsible for what during the entire process, from before the molecule has been discovered to the point where it is administered as a drug to patients.
Our course will combine teaching by experts, workshops and group work, meaning there will be plenty of opportunities for you to put your learning into practice and engage in discussions with your teachers and fellow students.
Keywords
- Definition of Target Product Profile
- Clinical Development Plans
- Clinical Development Phases
- Study Design and use of Clinical Data
- Pharmacovigilance During Development and After Marketing
- Data Monitoring During Clinical Trials
- Good Clinical Practice (GCP)
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Course leader(s) & Lecturer(s)
- Kirsten HartingCourse leaderMedical Doctor and Executive MBA
Pharma-Business - Claudia Pierleoni-NielsenLecturerSenior Director, Head of Medical Safety
Lundbeck A/S - Helen ShennanLecturerReguatory Affairs Head Nordic
AstraZeneca A/S - Dennis BrøndtLecturerSenior Manager, Global Channel Enablement
ALK - Christian WolffbrandtLecturerManager, Clinical Project Management
ALK - Niclas PetriLecturerPrincipal Clinical Pharmacology Scientist
Novo Nordisk A/S - Helle MirchandaniLecturerSr. Clinical Research Associate
Klifo A/S - Sofie de Fine LichtLecturerMedical Evidence Team Lead, Epidemiology and Real-World Evidence
AstraZeneca A/S - Anna Karina Trap HuusomLecturerBiometrics and Data Management
H. Lundbeck A/S - Mette SkovdalLecturerSr. Manager Medical Lead, Denmark & Iceland
Pfizer ApS - Søren Rousku AndersenLecturerSenior Sales Manager
Pfizer ApS - Tine Bryan StensbølLecturerSenior Vice President
H. Lundbeck A/S
See all
IS THIS COURSE FOR YOU?
This course is relevant if you are new in the field of clinical drug development, or if you are not directly involved in conducting clinical trials, but need to have a general understanding of clinical drug development. It is also suitable for you if you are considering working with clinical trials in the future.
What you will learn
- The basic principles of clinical drug development
- Study designs and different phases of drug development (Pre-clinical, Phase I, II & III studies, post-marketing studies)
- The importance of pharmacovigilance during study conduct and post-marketing
- The importance of data monitoring during clinical trials according to ICH Good Clinical Practice (GCP)
- The regulatory requirements in the drug development life cycle and market authorization process
What your company will get
- An employee who understands the basic principles of clinical drug development
- An employee who understands the importance of data monitoring and data safety (pharmacovigilance)
- An employee who understands the regulatory requirements during drug development and the market authorization process
- An employee who can provide valuable input to all other team members involved in clinical drug development
Course calendar
Choose your starting date
Starting 21 Nov 2022
Starting 1 Nov 2023
21 Nov 2022 8:30-16:00
DAY 1
- Clinical development plans and Target Product Profiles
- Why is clinical drug research conducted in the way it is today?
- Historical background
- Most important authorities and guidelines
- Clinical drug research: From molecule to patient
- Preclinical
- Phase I, II and III
- Study design
- Clinical results
- Stakeholders: roles and responsibilities
- Practical experience with pharmacovigilance in clinical studies: Adverse drug reactions in phases I-III
- Workshop
22 Nov 2022 8:30-16:00
DAY 2
- Dialog with regulatory bodies
- The regulatory process during development
- Submission of documentation to authorities
- Drug approval - marketing authorization
- Regulatory procedures after approval - life cycle management
- Clinical studies after approval
- Phase IV studies
- Why are further studies conducted after the drug has been approved?
- How are they designed? (Reference to a study design)
- Types of studies
- Post Authorization Safety Studies (PASS), NonInterventional Studies (NIS)
- Who conducts them (sponsors, competitors, investigators)?
- Pharmacovigilance after marketing: How do you monitor adverse drug reactions (ADRs) in real life contexts?
- ICH Good Clinical Practice (GCP) monitoring guidelines
- Why is monitoring necessary?
- How is monitoring done in practice?
- Consent - Distribution of responsibility: the sponsor’s, the CRO’s, the site’s (e.g. management of trial medicine), and the authorities’ responsibility? (inspections)
- Audits and inspections - being “inspection ready”
- Workshop
Practical information
Registration
Registration deadline14 Nov 2022
Atrium
Lersø Parkallé 101
2100 København Ø
RegisterLersø Parkallé 101
2100 København Ø
21 - 22 Nov
1 Nov 2023 8:00-17:00
DAY 1
- Clinical development plans and Target Product Profiles
- Why is clinical drug research conducted in the way it is today?
- Historical background
- Most important authorities and guidelines
- Clinical drug research: From molecule to patient
- Preclinical
- Phase I, II and III
- Study design
- Clinical results
- Stakeholders: roles and responsibilities
- Practical experience with pharmacovigilance in clinical studies: Adverse drug reactions in phases I-III
- Workshop
2 Nov 2023 8:00-16:00
DAY 2
- Dialog with regulatory bodies
- The regulatory process during development
- Submission of documentation to authorities
- Drug approval - marketing authorization
- Regulatory procedures after approval - life cycle management
- Clinical studies after approval
- Phase IV studies
- Why are further studies conducted after the drug has been approved?
- How are they designed? (Reference to a study design)
- Types of studies
- Post Authorization Safety Studies (PASS), NonInterventional Studies (NIS)
- Who conducts them (sponsors, competitors, investigators)?
- Pharmacovigilance after marketing: How do you monitor adverse drug reactions (ADRs) in real life contexts?
- ICH Good Clinical Practice (GCP) monitoring guidelines
- Why is monitoring necessary?
- How is monitoring done in practice?
- Consent - Distribution of responsibility: the sponsor’s, the CRO’s, the site’s (e.g. management of trial medicine), and the authorities’ responsibility? (inspections)
- Audits and inspections - being “inspection ready”
- Workshop
Practical information
Registration
Registration deadline25 Oct 2023
Atrium
Lersø Parkallé 101
2100 København Ø
RegisterLersø Parkallé 101
2100 København Ø
1 - 2 Nov
Sometimes things change. This is the expected programme.
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.
Prerequisites
There are no prerequisites for this course, but we recommend that you have a Bachelor’s degree or similar as a minimum.
Examination
There is no examination for this course.
Course leader(s)
Kirsten Harting
Medical Doctor and Executive MBAPharma-Business
Lecturer(s)
Claudia Pierleoni-Nielsen
Senior Director, Head of Medical SafetyLundbeck A/S
Helen Shennan
Reguatory Affairs Head NordicAstraZeneca A/S
Dennis Brøndt
Senior Manager, Global Channel EnablementALK
Christian Wolffbrandt
Manager, Clinical Project ManagementALK
Niclas Petri
Principal Clinical Pharmacology ScientistNovo Nordisk A/S
Helle Mirchandani
Sr. Clinical Research AssociateKlifo A/S
Sofie de Fine Licht
Medical Evidence Team Lead, Epidemiology and Real-World EvidenceAstraZeneca A/S
Anna Karina Trap Huusom
Biometrics and Data ManagementH. Lundbeck A/S
Mette Skovdal
Sr. Manager Medical Lead, Denmark & Iceland Pfizer ApS
Søren Rousku Andersen
Senior Sales ManagerPfizer ApS
Tine Bryan Stensbøl
Senior Vice PresidentH. Lundbeck A/S
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Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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