Modern Clinical Monitoring and Quality by Design.
Featuring Andrew Lawton, Geoffrey Mann and Ron Kenett
Medicon Valley Alliance and JMP Statistical discovery are hosting this exiting seminar on the benefits of data-driven analytics.
In the pharmaceutical industry there is no guidance which states that you must use data-driven analytics, yet this is the only effective way to meet the requirements imposed by regulatory agencies. The JMP family of products provide many capabilities that help you to leverage data better, and this seminar focuses on two distinct but related areas of application: The Impact of Regulatory Guidance on Analytics & Modern Techniques in Clinical Trial Monitoring.
Finally you will get an overview of the data-driven aspects of Quality by Design (QbD) and the associated FDA guidance.
Date: 27 October 2016
Time: 09:30 – 14:30
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Ground floor
Registration fee: FREE
Program:
9:30 | Registration and Coffee |
10:00 | Welcome and introductions |
10:10 | The Impact of Regulatory Guidance on Analytics |
10:55 | Modern Techniques in Clinical Trial Monitoring |
11:40 | Break |
12:10 | Using QbD to Increase Clinical, Product and Process Understanding |
12:55 | Conclusions and closing remarks |
13:05 | Networking Lunch |
Speakers:
The potential benefits of these cutting-edge methodologies are:
- Saving up to 30 percent of the costs of running trials.
- Identifying the causes of data quality issues faster.
- Reducing the frequency of interactions with regulatory agencies.
- Uncovering issues unidentifiable without central statistical monitoring methods.
- Managing pipeline risk with increased understanding.
- Accelerated new product introductions through knowledge re-use.
- Higher manufacturing yields.
As the pharmaceutical industry transitions into a more metrics based future, there has never been a better time to invest in realizing the enormous benefits of using data-driven analytics.
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