Introduction to Clinical Development

This course provides you with a general overview and understanding of why and how we do clinical drug development
21 - 22 Nov 2022
or
1 - 2 Nov 2023

On location

English

10,000 DKK ex VAT
(app. 1,344 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)

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Course leader(s) & Lecturer(s)

  • Kirsten Harting
    Course leader
    Medical Doctor and Executive MBA
    Pharma-Business
  • Claudia Pierleoni-Nielsen
    Lecturer
    Senior Director, Head of Medical Safety
    Lundbeck A/S
  • Helen Shennan
    Lecturer
    Reguatory Affairs Head Nordic
    AstraZeneca A/S
  • Dennis Brøndt
    Lecturer
    Senior Manager, Global Channel Enablement
    ALK
  • Christian Wolffbrandt
    Lecturer
    Manager, Clinical Project Management
    ALK
  • Niclas Petri
    Lecturer
    Principal Clinical Pharmacology Scientist
    Novo Nordisk A/S
  • Helle Mirchandani
    Lecturer
    Sr. Clinical Research Associate
    Klifo A/S
  • Sofie de Fine Licht
    Lecturer
    Medical Evidence Team Lead, Epidemiology and Real-World Evidence
    AstraZeneca A/S
  • Anna Karina Trap Huusom
    Lecturer
    Biometrics and Data Management
    H. Lundbeck A/S
  • Mette Skovdal
    Lecturer
    Sr. Manager Medical Lead, Denmark & Iceland
    Pfizer ApS
  • Søren Rousku Andersen
    Lecturer
    Senior Sales Manager
    Pfizer ApS
  • 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 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 deadline
14 Nov 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
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 deadline
25 Oct 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
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 MBA
Pharma-Business

Lecturer(s)

Claudia Pierleoni-Nielsen
Senior Director, Head of Medical Safety
Lundbeck A/S
Helen Shennan
Reguatory Affairs Head Nordic
AstraZeneca A/S
Dennis Brøndt
Senior Manager, Global Channel Enablement
ALK
Christian Wolffbrandt
Manager, Clinical Project Management
ALK
Niclas Petri
Principal Clinical Pharmacology Scientist
Novo Nordisk A/S
Helle Mirchandani
Sr. Clinical Research Associate
Klifo A/S
Sofie de Fine Licht
Medical Evidence Team Lead, Epidemiology and Real-World Evidence
AstraZeneca A/S
Anna Karina Trap Huusom
Biometrics and Data Management
H. Lundbeck A/S
Mette Skovdal
Sr. Manager Medical Lead, Denmark & Iceland
Pfizer ApS
Søren Rousku Andersen
Senior Sales Manager
Pfizer ApS
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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