Overview
Over the past decade, implementing disclosure and data transparency policies and procedures in clinical trials has become an essential requirement for anyone working in this area. Most of the major pharmaceutical companies have already established transparency policies, spontaneously giving the possibility to access the data collected during their clinical trials to anyone who requests it; at the same time, regulatory agencies such as European Regulatory Agency Policy (EMA), FDA, and the International Committee of Medical Journal The editors (ICMJE) have made the effective management and publication of data collected in clinical trials mandatory.
The management of confidential company data and patient personal data by the study sponsor must therefore be redefined; these requests will translate into an additional workload for
those working in the world of medical research, which must however be turned into a new opportunity of adding value to scientific communication. This workshop aims to provide practical tools to manage new requests proactively and effectively in terms of data transparency in clinical trials, producing benefits that go beyond compliance with the rules.
Who should attend?
The course is aimed at all company figures involved in the design, development, and communication of clinical studies on products of medical interest, including professionals working in
• Clinical Operations
• Regulatory
• Medical Affairs
• Clinical data registration
• Statistics
• Scientific Communications
• Medical Information
• Clinical Information
• Marketing
• Compliance
• Quality assurance
• Pharmacology
• CRM
• Transparency
• Legal
• Data management
• Real-World Data
Trainers
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