2024-12-04 2024-12-04 , online online, 1,990 € plus tax Alexander Maur https://www.forum-institut.com/seminar/25022110-regulatory-compliance-in-clinical-trials/referenten/25/25_02/25022110-webcast-series-regulatory-compliance-in-clinical-trials_maur-alexander.jpg Regulatory Compliance in Clinical Trials

Are you looking for a compact knowledge update on the regulations and guidelines in clinical drug trials to perform your daily work in a compliant and responsible manner? Then get comprehensive information in this webcast series!

Topics
  • Regulations in clinical crials: basic knowledge for your work
  • Patient and drug safety: guidelines, documentation, and reporting obligations
  • Compliance for sponsors of clinical trials: quality & risk management, data integrity
  • IMP compliance: responsibilities at the GCP/GMP interface


Who should attend
This webcast series is aimed at employees involved in clinical drug trials who:

  • require a compact compliance update on the essential regulations and requirements for their work in European clinical drug trials.
  • wish to obtain proof of their qualifications.

The training will be conducted in English.
Aims and objectives
To undertake a role in clinical drug trials, a comprehensive understanding of compliance, adherence to laws, regulations, and defined requirements is essential.

This 4-part webcast series provides you with a concise two-day knowledge update on all compliance requirements in clinical trials within the European scope.

Starting with the regulations that form the basis for all actions in clinical studies, you will learn about the requirements for patient and drug safety, as well as the responsibilities of sponsors in clinical trials. Data integrity, risk-based quality management, and collaboration with contract partners will also be covered, as will the correct handling of the investigational medicinal product itself.

Equipped with this knowledge, you will be able to carry out your work in clinical trials in Europe independently and in compliance with regulations.

A post-training examination ensures that the knowledge imparted is retained and readily applicable.
Your benefit

  • Compact knowledge update: all requirements for your daily work in European clinical drug trials
  • 4 Live webcast sessions over two days - perfectly integrated into your work schedule
  • Exam and certificate - your qualification proof for audits and inspections

You missed a webcast session? Don't worry - watch it later on-demand.

webcast series - Regulatory Compliance in Clinical Trialswebcast series - Regulatory Compliance in Clinical Trials

Regulatory Compliance in Clinical Trials

Your Responsibilities as a Sponsor at a Glance

Benefits
  • The guidelines for your daily work in European clinical trials
  • 4 live webcast sessions over two days
  • Highly experienced trainers
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25022110

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

24-25/02/2025

24-25/02/2025

Period

both days 09:00 - 12:00 and 13:00 - 16:00 CET

both days 09:00 - 12:00 and 13:00 - 16:00 CET
Venue

online

online

Fee
Your contact

Regine Görner
deputy department manager

r.goerner@forum-institut.de
v.kluever@forum-institut.de

Details

Are you looking for a compact knowledge update on the regulations and guidelines in clinical drug trials to perform your daily work in a compliant and responsible manner? Then get comprehensive information in this webcast series!

Topics

  • Regulations in clinical crials: basic knowledge for your work
  • Patient and drug safety: guidelines, documentation, and reporting obligations
  • Compliance for sponsors of clinical trials: quality & risk management, data integrity
  • IMP compliance: responsibilities at the GCP/GMP interface


Who should attend
This webcast series is aimed at employees involved in clinical drug trials who:

  • require a compact compliance update on the essential regulations and requirements for their work in European clinical drug trials.
  • wish to obtain proof of their qualifications.

The training will be conducted in English.

Aims and objectives

To undertake a role in clinical drug trials, a comprehensive understanding of compliance, adherence to laws, regulations, and defined requirements is essential.

This 4-part webcast series provides you with a concise two-day knowledge update on all compliance requirements in clinical trials within the European scope.

Starting with the regulations that form the basis for all actions in clinical studies, you will learn about the requirements for patient and drug safety, as well as the responsibilities of sponsors in clinical trials. Data integrity, risk-based quality management, and collaboration with contract partners will also be covered, as will the correct handling of the investigational medicinal product itself.

Equipped with this knowledge, you will be able to carry out your work in clinical trials in Europe independently and in compliance with regulations.

A post-training examination ensures that the knowledge imparted is retained and readily applicable.

Your benefit

  • Compact knowledge update: all requirements for your daily work in European clinical drug trials
  • 4 Live webcast sessions over two days - perfectly integrated into your work schedule
  • Exam and certificate - your qualification proof for audits and inspections

You missed a webcast session? Don't worry - watch it later on-demand.

Detailed programme

both days 09:00 - 12:00 and 13:00 - 16:00 CET

24.02.2025 09:00 - 12:00

Alexander Maur

Regulatory set-up - the basis for everything in clinical trials
  • ICH GCP E6 (R2) & (R3), ICH E8 (R1)
  • EU Clinical Trials Regulation - "reorganization" of clinical trials in Europe
  • National requirements in Germany (Arzneimittelgesetz)
  • Paediatric Regulation EC/1901/2006, Draft Regulation 2023/013, Draft Directive 2023/0132
  • Data protection, European area for Health Data (EDHS), Health Data Utilization Act (GDNG)
  • Data transparency, publication requirement of clinical study data

24.02.2025 13:00 - 16:00

Anja Braschoß

Patient safety and Drug safety
  • Safety data collection and clinical safety data management
  • Documentation and reporting obligations for AES, SAEs and SUSARs
  • Safety communication to authorities, EC and Data Safety Monitoring Boards
  • The EudraVigilance database
  • Dealing with non-compliance and reporting obligations

25.02.2025 09:00 - 12:00

Dr. Karen Edelmann-Stergiou

Compliance for sponsors of clinical trials
  • Quality management
    • Quality by design
    • Risk-based QM
    • Quality assurance and control
  • Compliance risks in cooperation with "service providers"
  • Data integrity and system validation - what brings ICH E6 (R3)?
  • Dealing with serious violations
    • Fraud and misconduct
    • Protocol compliance (ICH GCP E6 (R3))

25.02.2025 13:00 - 16:00

Dr. Stephanie Blum

IMP compliance
  • CTR 536/2014, Detailed Commission Guidelines on GMPs for IMPs, Commission Delegated Regulation (EU) 2017/1569 and more...
  • Manufacture, labeling, blinding, storage, transport
  • Batch release
  • Importation from third countries
  • IMPD and Product Specification File
  • Sponsor and QP - shared responsibilities
  • Vendor management and contracts

Further information

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

This distinguishes our events

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Go forward

List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
List of abbreviations
In-house seminars

Our programmes are also available for in-house training. Just contact us!

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In-house seminars
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality