Introduction to Clinical development

This course provides you with a general overview and understanding of why and how we do clinical drug development

11. Nov 2021
9. Nov 2022

2 days course

English

8,670 DKK ex VAT
(app. 1,166 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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)

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

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Course leader(s) & Lecturers

  • Kirsten Harting
    Course leader
    Medical Manager
    Pharma-Business
  • Helen Shennan
    Lecturer
    Regulatory Affairs Head
    AstraZeneca A/S
  • Claudia Pierleoni-Nielsen
    Lecturer
    Senior Director, Head of Medical Safety
    Lundbeck A/S
  • Nils Ole Ole Dalby
    Lecturer
    MSL
    Arvelle Therapeutics
  • Lars Mandrup
    Lecturer
    Owner
    Pharma "M" Consultancy
  • Lone Roslev
    Lecturer
    Clinical Trial Manager/CR
    KLIFO A/S
  • Søren Lophaven
    Lecturer
    Ph.D., Statistician
    Omicron ApS
  • Arun Micheelsen
    Lecturer
    Chefkonsulent
    DLI Market Intelligence ApS
  • Birgitte Søgaard
    Lecturer
    Chief Scientist
    H. Lundbeck A/S
  • Søren Rousku Andersen
    Lecturer
    Senior Sales Manager
    Pfizer ApS
  • Peter Bergqvist
    Lecturer
    Medical Writer, Owner
    Öresund Medical Writing AB
  • Christian Wolffbrandt
    Lecturer
    Manager, Clinical Project Management
    ALK
  • Tine Bryan Stensbøl
    Lecturer
    Senior 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

  1. The basic principles of clinical drug development
  2. Study designs and different phases of drug development (Pre-clinical, Phase I, II & III studies, post-marketing studies)
  3. The importance of pharmacovigilance during study conduct and post-marketing
  4. The importance of data monitoring during clinical trials according to ICH Good Clinical Practice (GCP)
  5. The regulatory requirements in the drug development life cycle and market authorization process

What your company will get

  1. An employee who understands the basic principles of clinical drug development
  2. An employee who understands the importance of data monitoring and data safety (pharmacovigilance)
  3. An employee who understands the regulatory requirements during drug development and the market authorization process
  4. An employee who can provide valuable input to all other team members involved in clinical drug development

Course calendar

Choose your starting date
Starting 11. Nov 2021
Starting 9. Nov 2022
11. Nov 2021 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
12. Nov 2021 8:30-15:30

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 deadline
4. Nov 2021
Atrium
Lersø Parkallé 101
2100 København Ø
Register
11 - 12 Nov
9. Nov 2022 9:00-16:00

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
10. Nov 2022 9:00-16:00

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 deadline
2. Nov 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
9 - 10 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 Manager
Pharma-Business

Lecturers

Helen Shennan
Regulatory Affairs Head
AstraZeneca A/S
Claudia Pierleoni-Nielsen
Senior Director, Head of Medical Safety
Lundbeck A/S
Nils Ole Ole Dalby
MSL
Arvelle Therapeutics
Lars Mandrup
Owner
Pharma "M" Consultancy
Lone Roslev
Clinical Trial Manager/CR
KLIFO A/S
Søren Lophaven
Ph.D., Statistician
Omicron ApS
Arun Micheelsen
Chefkonsulent
DLI Market Intelligence ApS
Birgitte Søgaard
Chief Scientist
H. Lundbeck A/S
Søren Rousku Andersen
Senior Sales Manager
Pfizer ApS
Peter Bergqvist
Medical Writer, Owner
Öresund Medical Writing AB
Christian Wolffbrandt
Manager, Clinical Project Management
ALK
Tine Bryan Stensbøl
Senior Vice President
H. Lundbeck A/S

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WANT TO KNOW MORE or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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