First Asia Regulatory Conference, "Asia's Role in Global Drug Development"

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...

Date(s) And Time(s):
Apr 26 2011 8:00AM - Apr 28 2011 5:00PM

Location:
Grand Hilton Seoul
201-1, Hongeun-dong
Seodaemun-gu
Seoul, 120-710
Korea, Democratic People's Republic of

Overview:

SAVE THE DATE
The Conference is being convened in recognition of the launch of the APEC Harmonization Center

DAY ONE
Plenary Session — Update on ICH Activities, Focus on New Activities
• A Refl ection on 20 years ICH and the Way Forward
• Participation by Regulatory Leaders from ICH Regions
• Current Hot Topics: Q11 (Drug substance) and Potential Revision of
E2C (PSUR)
• Expanding the Participation in Expert Working Groups for RHIs and
DRAs
Parallel Tracks
• Anti-counterfeit Technologies in Low-resource Settings
• Ensuring Quality, Update on ICH Q8, Q9, Q10, and Q11
• Practical Uses of CTDs in Asia
Plenary Session — Regional Harmonization Initiatives
• APEC Harmonization Center
• Recent Developments under APEC Life Science Innovation Forum (LSIF)
• Tripartite Workgroup on Rationalization of Clinical Trial Requirements

DAY TWO
Plenary Sessions – Early and Late Clinical Development in Asia
• Role of Asia | Early Clinical Development in Asia
• Regional Clinical Trials | Acceptance of Clinical Data
• Simultaneous Multi Regional Clinical Trials
• Towards Simultaneous Regulatory Approval
Parallel Tracks
• Clinical Development: Integrating Children in Global Programs: Ethical, Clinical, and Regulatory Aspects
• Ensuring Quality: Harmonizing CMC Requirements
• Ethical Business Practices: Self-regulation and Government’s Oversight
Plenary Session
• Similar Bio-therapeutic Products
DAY THREE
Plenary Sessions
• Electronic Submissions and eCTD as Vehicle to Reconcile Differences in Technical Regulatory Requirements
• Pharmacovigiliance: How Regulatory Agencies and Industry Work Together to Protect Patients
• Good Regulatory Practices, Including Efficient Use of CPPs and Transparency

Event Code:
11910

Contact Information:

For general inquiries and registration, contact Lisa T.
Robinson at ltrobinson@kellencompany.com