Pharmacovigilance Data in Application and Registration

Understand the relationship between pharmacovigilance and the processes of application and registration

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25 - 26 Nov 2024

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On location or online

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English

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Online 12,500 DKK
On location 13,500 DKK

Summary

Module 6

This two day course will help you understand the relationship between pharmacovigilance and the processes of application and registration. We will focus on the areas and phases in drug development processes where the clinical development, registration, and pharmacovigilance units co-operate closely.



    Keywords

    • Clinical Trial Protocol
    • Clinical Study Report
    • Summary of Clinical Safety and Clinical Overview
    • Post Authorization Safety Studies (PASS)
    • Summary of Product Characteristics (SPCs)
    • Risk Management Plan
    • Evaluation of Applications for New Medicinal Products by Authorities

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    Course leader & lecturers

    • Bodil Svanholm Fogh
      Course leader
      Senior Specialist, Safety Scientist
      H. Lundbeck A/S
    • Nanco Hefting
      Lecturer
      Chief Specialist
      H. Lundbeck A/S
    • Jens Heisterberg
      Lecturer
      VP, Regulatory Policy and Intelligence
      Novo Nordisk A/S
    • Maurizio Sessa
      Lecturer
      Assistant Professor of Pharmacoepidemiology
      Københavns Universitet
    • Claudia Pierleoni-Nielsen
      Lecturer
      Director, Head of Safety Surveillance, Global Safety
      Leo Pharma A/S
    • Samuel David Ramsden
      Lecturer
      Head of Risk Management Office
      Boehringer Ingelheim Pharma GmbH & Co. KG
    See all

    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

    1. The relationship between pre-marketing clinical safety and the processes of application and registration
    2. How to analyze the different pre-application tasks related to clinical safety and turn them into an application for marketing authorisation
    3. The application’s implications for post-authorisation pharmacovigilance

    What your company will get

    1. A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
    2. A safety and pharmacovigilance professional that can independently analyze the different pre-application tasks related to pharmacovigilance
    3. An employee who can play an important role in any interdisciplinary project team
    4. An employee who can provide valuable input on how to improve cooperation between the clinical development, registration and pharmacovigilance units

    Course calendar

    Starting 25 Nov 2024
    25 Nov 2024 9:00-16:00
    Day 1
    • Clinical development plan
    • Clinical trial reports with special focus on the safety sections
    • Risk Management Plan
    • Clinical Safety Summary and Clinical Overview
    • Evaluation of safety data from the authorities' perspective
    26 Nov 2024 9:00-16:00
    Day 2
    • Safety data in labeling / Summary of Product Characteristics
    • Pharmacovigilance Risk Assessment Committee's (PRAC's) function
    • Risk-Benefit Framework
    • Post Authorization Safety Studies (PASS)
    Practical information

    Related exams

    10 Jan 2025 10:00-13:00
    Go to exam page

    Registration

    Registration deadline
    18 Nov 2024
    Register
    25 - 26 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.

    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 is held online, usually 4-6 weeks after the course.

    You will receive a link with exam questions via your personal Atrium log-in.

    In order to participate in the exam, you must have attended the course.

    This course is a part of a diploma

    Diploma in Pharmacovigilance

    The demand for qualified pharmacovigilance professionals is high. Become a sought after and highly valued professional by attending our pharmacovigilance training and acquire the Diploma in Pharmacovigilance.

    Read more

    Course leader

    Bodil Svanholm Fogh
    Senior Specialist, Safety Scientist
    H. Lundbeck A/S

    Lecturers

    Nanco Hefting
    Chief Specialist
    H. Lundbeck A/S
    Jens Heisterberg
    VP, Regulatory Policy and Intelligence
    Novo Nordisk A/S
    Maurizio Sessa
    Assistant Professor of Pharmacoepidemiology
    Københavns Universitet
    Claudia Pierleoni-Nielsen
    Director, Head of Safety Surveillance, Global Safety
    Leo Pharma A/S
    Samuel David Ramsden
    Head of Risk Management Office
    Boehringer Ingelheim Pharma GmbH & Co. KG

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    Want to know more or need help?

    Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

    Send me a message