Training Archives | European Regulatory Affairs Specialists

The Clinical Trials Information System is a harmonised and simplified end-to-end single entry point for clinical trials information in the European Union and in the European Economic Area and will go live on 31 January 2022.

As a single entry point, it will be used for the submission, management and assessment of information throughout the life cycle of a clinical trial. The exchange of information between sponsors and Member States will be fully electronic.

In a recent EMA training webinar, the EMA advise the following to prepare for the CTIS go live date:

Read the CTIS Sponsor Handbook
Read the CTIS Training Modules, particularly Module 19 (CTIS for SMEs and academia)
Ensure the organisation is registered and correct in SPOR
Familiarise yourself with the CTIS User Personas
Register Users in the EMA account management
Register the first Sponsor Administrator
Ensure your product is registered in the Article 57 database (XEVMPD)
Prepare your CTA and supporting documents in accordance with CTR requirements
Sign up to the CTIS Highlights Newsletter (write to communication@ema.europa.eu )

EMA has launched the CTIS training webpage containing a substantial amount of training materials and information for the users and organisations to facilitate their preparedness.

Should you need any support in clinical trial application just contact us and the Ivowen team will be here to help.

Written by Fiona Downey

In an ever changing and at times a fast paced environment the world of pharmaceuticals demands cohesion and understanding across the board, to allow growth and success in any business either directly or indirectly involved with it. With regulations and guidelines becoming more stringent and extensive along with constant revisions and updates of the same it can be hard to keep up. It is important that you and your colleagues have an understanding of these guidelines that relate to the work that you do to ensure safety of patients and company compliance.

In certain instances guidelines and recommendations are hundreds of pages long and differ between countries, this places huge time pressure on individuals and businesses to keep up to date and often a brief read over them leaves people feeling a little confused and sometimes without even a basic understanding as to what actually needs to be done.

IVOWEN are here to help you gain a better understanding of, and, confidence in, current guidelines and technical updates. Ivowen has always offered training in many areas of pharmaceuticals but are now looking at providing these training sessions online to help our clients to gain a higher level of expertise through easier access.

We would be very grateful if you could complete the online survey we have created to help us assess how the online training sector can benefit our clients.

It takes less than 3 minutes to complete and would help us immensely:

https://ivowen.typeform.com/to/drre5H

Thank you for your feedback.