Title: Face-to-face meeting: EMA regulatory process for clinical trials
Trainer: Laura Brown
Duration: 1 day
Date and time: 1 March 2019; 09:00–16:30
Location: Amsterdam, Netherlands
CME accreditation: Pending
09:00–09:20
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Welcome and introductions |
All |
09:20–10:00 |
S1: Key regulatory and guidelines requirements
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10:00–11:00 |
S2: The importance of ICH GCP R2 guideline requirements
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11:00–11:20 |
Refreshment break and interactive poster wall |
All |
11:20–12:15 |
S3-a Practical exercise: Setting up a clinical trial
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Workshop/working in smaller groups
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12:15–13.00 |
Lunch |
All |
13:00–14:00 |
S3-b Practical exercise: setting up a clinical trial (continued)
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Workshop/working in smaller groups
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14:00–14:30 |
S4 Managing investigational medicinal products
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14:30–15:15 |
S5 Pharmacovigilance requirements
Including refreshments in the room |
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15:15–15:45 |
S6: Legal aspects of clinical trials
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15:45–16:30 |
S7: Latest developments: GDPR (May 2018)
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16:30 |
Summary and close |
All |