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) & Lecturers
- Kirsten HartingCourse leaderMedical Manager
Pharma-Business - Helen ShennanLecturerRegulatory Affairs Director
AstraZeneca A/S - Claudia Pierleoni-NielsenLecturerSenior Director, Head of Medical Safety
Lundbeck A/S - Nils Ole DalbyLecturerMSL
Arvelle Therapeutics - Lars MandrupLecturerOwner
Pharma "M" Consultancy - Lone RoslevLecturerClinical Trial Manager/CR
KLIFO A/S - Søren LophavenLecturerPh.D., Statistician
Omicron ApS
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
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
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
Registration
Registration deadline4. Nov 2021
Lersø Parkallé 101
2100 København Ø
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
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
Registration
Registration deadline2. 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.
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)
Pharma-Business
Lecturers
AstraZeneca A/S
Lundbeck A/S
Arvelle Therapeutics
Pharma "M" Consultancy
KLIFO A/S
Omicron ApS
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