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WORKSHOPS
Monday, 17 September, 2012
WORKSHOP A
0900 – 1200: Monday, 17 September 2012
(inclusive of 30-min refreshment and networking break)
Practical steps in preparing
for PV inspection
To ensure regulatory compliance, inspections are conducted
regularly which require much and careful preparation work.
Different stakeholders will be involved as well which adds
to the complexity. It is critical for the team to be properly
prepared and make sure every step is right to lead to a
fruitful inspection.
Dr. Ming Ji will share through his vast experience in this
field the common challenges, and give insights on practical
steps to prepare for PV inspection.
WORKSHOP AGENDA
0830 Registration
0900 Welcome from Workshop Leader
0905 Understanding PV inspections
• purposes
• inspection documents
• key requirements
• reporting timeline
0930 What to prepare
• before
• through and
• after an inspection
1000 Preparing documents
• what are they
• which sections require special attention
• acquiring information from departments
1030 Refreshment and Networking Break
1100 Developing good communications strategies
• why communications are important
• common challenges and impact on inspection
results
• what works best
1130 Conducting a mock inspection
1200 End of workshop
About your workshop leader:
Dr. Ming Ji, MD, MS.
Senior Medical Director, Global Pharmacovigilance
Abbott
Dr. Ming Ji had extensive experience in clinical drug
safety, pharmacovigilance and clinical pharmacology.
Prior to his current post, Dr. Ji served as medical director
at Pharmacovigilance Department of TAP Pharmaceutical
Inc., executive director at Global Safety of Amgen Inc., and
medical monitor in Clinical Development of Wyeth.
WORKSHOP B
1400 – 1700: Monday, 17 September 2012
(inclusive of 30-min refreshment and networking break)
Achieving compliance with various
country regulations in Asia while
meeting company global safety
requirements
As Asia presents the largest growth opportunity for
pharmaceutical industry, many are taking foothold in
Asia to gain market share. One major challenge faced is
to ensure compliance with various country regulations,
which are rapidly changing and evolving. In addition, the
company’s global safety requirements add to the burden of
pharmacovigilance professionals.
In this workshop, you will learn how to effectively comply
with various country regulations in Asia while meeting
company’s global safety requirements.
WORKSHOP AGENDA
1330 Registration
1400 Welcome from Workshop Leader
1405 Understanding PV regulations in Asia
• What are PV regulatory requirements in Asian
countries
• How PV regulations differ in various countries
• Implications for PV managers
1430 Achieving compliance in Asia
• what areas to look out for
• ensuring due diligence
• conducting mock inspections internally
1500 Making compliance simple
• SOPs to incorporate regulatory requirements
• company global safety requirements
1530 Refreshment and Networking Break
1600 Case study of Sanofi-Pasteur
• what it does to comply with Asian regulations and
company global safety requirements
• common challenges and impact on PV compliance
• strategies to overcome the challenges
1630 Hands-on application
• how your PV practices can be improved
• will Sanofi-Pasteur’s way work for you
• Modifying your PV practices to make compliance
reliable and simple
1700 End of workshop
This workshop will be led by an industry expert. 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