Signal Detection Strategies
successfully devise your pharmacovigilance plan
Course Objectives:
Signal detection plays a crucial role in your drug safety profile – the rapid identification of potential unwanted side effects is a key component in the drug discovery pathway. But over the last 10 years, assessing clinical and postmarketing data has become a lengthy and complex process. The WHO database alone carries more than 2.8 million case reports from 70 countries and regulators are imposing increasingly strict harmonisation guidelines.
Finding a complex pattern really can be compared to looking for a needle in a haystack. But with the right signal detection strategies in place, companies can substantially strengthen and development screening programmes for faster, more efficient early safety signal detection.
PTI’s 2-day interactive course is the third in our Adverse Event Reporting curriculum. Join our distinguished trainer and learn how these strategies can change the way you apply signal detection for the better!
What Will You Learn?
- Reduce early, or late stage, set backs in the registration procedure read more
- Ensure your signal detection methods are ICH E2E compliant
- Determine risk using early clinical data
- Implement score systems to detect signals using a qualitative approach
- Prepare for a pharmacovigilance inspection
Why you should attend:
Join us at Signal Detection Strategies to:
- Gain the atest data mining techniques for optimum risk assessment
- Clarify ICH E2E Step 2 for compliant Pharmacovigilance Planning
- Strengthen and development your existingscreening programmes for efficient early signaldetection
Dates and Venues
24 Nov 2010 - 25 Nov 2010
Regus Poultry, London, UK
Featured Session:
Group exercise:
Crisis? What Crisis?
During this exercise, delegates will work through a scenario where a strong signal has been detected. Emphasis will be
placed on how to deal with the regulators, press and public relations. Developing procedures for managing PR impact and
product withdrawal will also be discussed.
Who Should Attend?
This course will meet the training needs of personnel responsible for:
• Drug Safety
• Pharmacovigilance
• Regulatory Affairs
• Clinical Development
• Clinical Research Organisation
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
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