Presentations from 14th International Conference of Drug Regulatory Authorities (ICDRA)
30 November - 3 December 2010
Singapore 2010
Pre-Conference - 28-29 November 2010
Plenary 1 - 28 November 2010
Plenary 2 - 28 November 2010
Workshop A - 28 November 2010
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South-South Cooperation: the experience of ANVISA in the Americas, Africa and Asia
pdf, 1.28Mb -
Worksharing Consortium
pdf, 333kb
Workshop B - 28 November 2010
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International Nonproprietary Names: Current Status and Future Challenges
pdf, 5.87Mb -
Pharmacovigilance and the role of MedDRA in Regulatory Reporting
pdf, 416kb
Workshop C - 28 November 2010
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The Network of Regulatory Authorities for Paediatric Medicines (PmRN)
pdf, 4.89Mb -
The Advantage of Information Available from USFDA
pdf, 3.31Mb
Workshop D - 28 November 2010
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Recent APEC Developments in Promoting Regulatory Harmonization and Capacity Building
pdf, 2.45Mb -
EAC Partner States' Medicines Registration Harmonization Initiative
pdf, 3.66Mb -
Regulatory Capacity Building in Mozambique: Cooperation with Brazilian Regulatory Authority
pdf, 582kb
Workshop E - 29 November 2010
Workshop F - 29 November 2010
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Towards a Robust and Internationally-Recognized GMP Inspection System
pdf, 12.78Mb -
Building a Collaborative Sharing Consortium in the Eastern African Community Partner States
pdf, 1.58Mb
Workshop G - 29 November 2010
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EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe and Beyond
pdf, 1.98Mb -
API Inspections: WHO Prequalification Experience
pdf, 12.26Mb
Workshop H - 29 November 2010
Workshop I - 29 November 2010
Workshop J - 29 November 2010
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Core Information for Regulatory Decision Making from SADC Regulator's Perspective
pdf, 603kb -
Enabling Access to Vaccines Through Better National Regulatory Authority Collaboration and Harmonization of Clinical Trials Application Regulatory Procedures
pdf, 981kb
Workshop K - 29 November 2010
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Mutual Recognition Between the EU Member States
pdf, 4.05Mb -
Current Status and Future Perspective for Mutual Recognition in the Context of ASEAN Collaboration
pdf, 262kb
Workshop L - 29 November 2010
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Provision and Exchange of Information
pdf, 1.24Mb -
Benchmarking Best Practices and Performance as a Potential Tool for Increasing Mutual Trust
pdf, 1.44Mb
Conference 30 November - 3 December 2010
30 November 2010
Plenary 1 on 13th ICDRA
Plenary 2
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Progress Report on Recommendations made at the 13th ICDRA, Bern, 2008
pdf, 1.78Mb -
Progress Report - WPRO
pdf, 530kb -
Progress Report - SEARO
pdf, 1.80Mb -
Progress Report - AFRO
pdf, 519kb -
Progress Report - AMRO
pdf, 1.10Mb -
Progress Report - EMRO
pdf, 38kb -
Progress Report - EURO
pdf, 291kb
Workshop A
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Blood and Blood Products
pdf, 16kb -
WHA Resolution on Availability, Safety and Quality of Blood Products
pdf, 414kb -
Impact of WHO Guidelines on GMP for Blood Establishments
pdf, 303kb -
Regulation of Advanced Blood Cell Therapies
pdf, 867kb -
Development of Assessment Tools for Evaluation of Blood System Regulation
pdf, 2.96Mb
Workshop B
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Challenges and Opportunities in Regulating Herbal Medicines in Indonesia
pdf, 1.67Mb -
Challenges Relating to Herbal Medicines: Adulteration of Herbal Medicines
pdf, 3.89Mb -
Regulatory Challenges Relating to Herbal Medicines: Evidence for Health Claims
pdf, 269kb -
International Regulatory Cooperation for Herbal Medicines (IRCH)
pdf, 601kb -
Challenges in Regulating Herbal Medicines in Ghana
pdf, 34kb
Workshop C
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Optimising Clinical Trials Design for Paediatric Populations
pdf, 2.07Mb -
Paediatric Clinical Trials in Malaysia
pdf, 4.86Mb -
Availability of Essential Medicines for Children in South Africa
pdf, 1.24Mb -
Availability of Essential Medicines in Ghana
pdf, 3.14Mb
Workshop D
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MenAfrivac - A long-waited vaccine for Burkina Faso
pdf, 997kb -
Linking Regulatory Decisions and Public Health Decisions for Vaccines: The Indonesian Experience
pdf, 1.60Mb -
Unexpected Finding of Adventitious Agent in a Biological Product: A Regulatory Perspective
pdf, 95kb
1 December 2010
Plenary 3
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Challenges of Biomedical Advancement - Evolving Role of the Regulator
pdf, 2.15Mb -
Improving Drug Regulation as part of Health System Strengthening
pdf, 750kb
Plenary 4
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Recent Developments in Cooperation of Regulatory Authorities among ASEAN Countries
pdf, 258kb -
Collaboration among the Regulatory Authorities in the EU: a micro-agency's perspective
pdf, 4.93Mb -
First Joint Product Assessment Experience from EAC Partner States
pdf, 462kb -
Recommendations from Pre-ICDRA Meeting
pdf, 146kb
Workshop E
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What did we learn from the A/H1N1 Influenza Pandemic? The Swiss Experience
pdf, 3.51Mb -
H1N1 Pandemic: Lessons Learnt
pdf, 6.20Mb -
The International Dimension of the Regulatory Response to the H1N1 Pandemic
pdf, 828kb
Workshop F
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Implementation of New EU Bioequivalence Guidelines
pdf, 1.64Mb -
Assessment of Bioequivalence Studies: Experience from WHO Prequalification of Medicines Programme
pdf, 2.54Mb -
Bioequivalence Study Registration Requirements in Ethiopia (Four Countries Experience)
pdf, 669kb -
How to Prove Interchangeability of Generic Drugs with Originators
pdf, 3.37Mb
2 December 2010
Workshop G
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Minimal Capacity in Country Global Vaccine Safety Blueprint
pdf, 1.35Mb -
Working Together with the Public Health Programmes: A Regulator's Perspective for Addressing the Minimum requirements for Pharmacovigilance
pdf, 2.27Mb -
Development of ADR Reporting and Monitoring in China
pdf, 1.04Mb -
Pharmacovigilance in Ukraine: Focus on ARV Treatment
pdf, 522kb
Workshop H
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Innovative Regulatory Review Practices for Better Efficiencies - The Singapore Experience
pdf, 3.27Mb -
Establishing Quality Management Systems
pdf, 3.45Mb -
Good Regulatory Practices: Developing Business Process
pdf, 414kb
Workshop I
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Implementation of Medicines Stability Testing Requirements
pdf, 3.94Mb -
Stability
pdf, 325kb -
Stability Studies: Experience of assessing stability data provided by the applicants to the Prequalification Programme
pdf, 1.48Mb -
Stability Evaluation of Vaccines: Lessons Learnt
pdf, 391kb
Workshop J
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Impact of Trial Design on GCP Inspections
pdf, 184kb -
Japan's Activities and Challenges to Promote Multi Regional Clinical Trials
pdf, 1.87Mb -
Establishing a Mechanism to Avoid "Shopping Around" for Ethical Approval
pdf, 589kb
Workshop K
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Education and Training Programs to Promote Professional Competency
pdf, 844kb -
Specific Capacity Building for the Inspectorate: ANMAT Experience
pdf, 223kb -
Parallel review of experience of vaccine by two authorities: benefits for providers/recipients and lessons learnt
pdf, 1.29Mb -
EU Experience in Training Regulatory Officials - Developing Coordinated Approaches
pdf, 115kb
Workshop L
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Medicines Promotion and Rational Use: The Spanish Experience
pdf, 662kb -
Generic Entries of New Chemical Entities: Challenges for Controlling Promotion and Ensuring Safety
pdf, 995kb -
Rational Use: Up from Down Under
pdf, 6.35Mb
Workshop M
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Anti-counterfeiting Situation in China
pdf, 139kb -
European Medicines Enforcement Network
pdf, 616kb -
Fight Against Counterfeit Medical Products: The Medicrime Convention and the Swiss Experience
pdf, 2.08Mb -
Struggle Against Counterfeit Medicines in Russia: An Overview
pdf, 19.60Mb
Workshop N
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Snake Antivenom Immunoglobulins
pdf, 2.18Mb -
Experience of Regulating Antisera: Possibilities for International Cooperation to Ensure Quality and Availability
pdf, 1.02Mb -
Quality of Venoms - A Critical Step for the Manufacture of Anti-Snake Venoms
pdf, 1.47Mb -
impact of the WHO Website on the Regulatory Control of Snake Antivenom
pdf, 1.03Mb
3 December 2010
Plenary 5
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Biosimilars
pdf, 261kb -
Biosimilars: Diversity of Regulatory Requirements and Way Forward
pdf, 5.47Mb -
Regulatory Consideration for Biosimilar Products
pdf, 4.38Mb -
Regulatory Framework in Cuba
pdf, 167kb
Plenary 6
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Transparency in Medicine Regulation: A Key for Measurable Achievement
pdf, 17.94Mb -
Electronic Nicotine Delivery Devices: Challenges and Opportunities
pdf, 1.66Mb -
Important Regulatory Steps being Taken in Cambodia to Phase Out Oral Artemisinin-based Monotherapies
pdf, 8.59Mb -
Security of Pharmaceuticals: Causes of Medicine Shortages in UK and Globalisation
pdf, 197kb -
Combating Antimicrobial Resistance: What Can Regulators Do?
pdf, 1.08Mb