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WORKSHOPS
Thursday, 20 September, 2012
WORKSHOP C
0900 – 1200: Thursday, 20 September 2012
(inclusive of 30-min refreshment and networking break)
Developing Risk Management Plans
(RMP) for Improved Post-Marketing
Drug Safety Surveillance
Risk management planning (RMP) has been developped in
EU and US for improved post-marketing drug surveillance.
In EU, it is mandatory for companies to submit a RMP at the
time of application for a Marketing Authorization for most
products.
With fast evolving regulations in Asia to address drug safety,
RMP will soon be adopted and implemented. In fact, Korea
annouced draft REMS (similar to RMP) in August 2011, to
be mandatory in 201 7, and Taiwan announced RMP draft in
2011 and started PV inspections in September 2011.
This workshop will equip you with knowledge on specific
elements of a RMP, the detailed template and guidelines,
and how you can develop RMP to improve your postmarketing
drug safety surveillance.
WORKSHOP AGENDA
0830 Registration
0900 Welcome from Workshop Leader
0905 Understanding RMP
• purposes
• when to submit a RMP
• what are the key elements
0930 Element 1: safety specification
• defining identified and potential risks
• limitations of clinical research program
• missing information of drug safety
1000 Element 2: pharmacovigilance plan
• what is the scope
• what plan details are required
• resolving the uncertainties in drug safety
1030 Refreshment and Networking Break
1100 Element 3: risk minimization plan
• the plan’s scope and purposes
• measures to reduce severity or frequency of
known ADRs
1130 Hands-on exercise to develop a RMP for your
company
1200 End of workshop
This workshop will be led by an industry expert on RMP.
Look out for our workshop leader announcement at
www.pharmacovigilanceasia.com.
WORKSHOP D
1400 – 1700: Thursday, 20 September 2012
(inclusive of 30-min refreshment and networking break)
Establishing an Effective Early
Detection System to Identify Safety
Issues Early for Quick Rectifications
Rare but serious adverse events associated with drugs
are often nearly impossible to detect in pre-licensure
studies and require monitoring after introduction to market.
Pharmaceutical companies thus look to buidling an
effective early detection system to identify safety issues
early for quick rectifications.
This workshop will equip you with knowledge and strategies to:
• aggregate and integrate drug safety data from
various sources
• uncover hidden insights in unstructured sources
• mitigate potential post-marketing risks
• drive better drug development decisions
WORKSHOP AGENDA
1330 Registration
1400 Welcome from Workshop Leader
1405 Understanding early detection system
• the purposes
• significance of early detection system for
drug safety
• common methodologies and analytical methods
1430 Data input
• various sources of data
• transform, cleanse and standardise data
• aggregate and integrate drug safety data
1500 Uncovering hidden insights
• unstructured texts and their importance to drug
safety
• text mining and proactive scanning for safety
signals
1530 Refreshment and Networking Break
1600 Improving drug development decisions
• methodologies in early detection system
• strengths and limitations of analytical methods
• applying early detection system throughout a
drug’s life cycle
• case study
1630 Hands-on application
• limitations in your early detection system
• how your early detection system can be
improved
1700 End of workshop
This workshop will be led by an industry expert on
establising early detection systems. Look out for our
workshop leader announcement at
www.pharmacovigilanceasia.com.
PHONE: (65) 6722 9388 • FAX: (65) 6720 3804 • EMAIL: enquiry@iqpc.com.sg • WEB: www.pharmacovigilanceasia.com