Overview
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical
Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise
procedures for carrying out clinical trials across the EU and to simplify the clinical trial
approval dossier by submission through a new clinical trial database and portal.
Guidelines for enacting the new Regulation have also been prepared in a number of areas
including inspection, investigational medicinal products and trial documentation.
This course will provide an essential understanding to help with compliance with the new
Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.
Who should attend?
This course is ideal for anyone requiring an update on the EU Clinical Trial Regulation
(536/2014).
The course is relevant for those working in:
• Regulatory
• Clinical research
• Clinical operations
• Project management
• Pharmacovigilance
• Quality assurance (GCP auditors)
• Vendor/CRO professionals
• Study sites
And other professionals in pharmaceutical and biotechnology organisations conducting
trials with drugs, biologics or combination products.
It will also be of interest to those departments who liaise with/support clinical trial personnel,
and all other professionals who want to know more about this important new regulation.
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Key Topics
Learning Outcomes
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FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up