Presentations from 13th International Conference of Drug Regulatory Authorities (ICDRA)
16 to 19 September 2008 - Berne, Switzerland
Plenary 2 on 12th ICDRA
WHO Progress Report from countries: Regional perspectives (WHO Regional Advisers on Pharmaceuticals)
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AFRO Progress Report
pdf, 102kb -
AMRO Progress Report
pdf, 241kb -
EMRO Progress Report
pdf, 202kb -
EURO Progress Report
pdf, 39kb -
SEARO Progress Report
pdf, 189kb -
WPRO Progress Report
pdf, 853kb
Workshop A - Regulatory Aspects of Paediatric Medicines
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Recent legislative changes regarding paediatric medicines in the European Union
pdf, 208kb -
Clinical trials in neonates - challenges for all stakeholders?
pdf, 684kb -
Paediatric medicines: a viewpoint from an African regulator
pdf, 111kb -
Report from the Pre-Conference "Better medicines for children - the way forward"
pdf, 31kb -
Recommendations from the Pre-Conference - Vaccines and Biologicals Track
pdf, 84kb
Workshop B - Development of Regulation for Herbal Medicines
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Regulatory Framework: Overview of the regulation of herbal medicines in Switzerland
pdf, 107kb -
Regulatory Framework: Overview of the regulation of herbal medicines in Brazil
pdf, 115kb -
Regulatory Framework: Overview of the regulation of herbal medicines in Benin in supporting Primary Health Care needs
pdf, 36kb -
Overview: revising the regulatory framework of herbal medicines in China
pdf, 541kb -
Regulatory cooperation IRCH
pdf, 86kb -
Regulatory aspects of Ayurvedic, Siddha & Unani Medicines
pdf, 47kb
Workshop C - Safety and Pandemic Preparedness
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Medicines and associated regulatory issues relevant in the pandemic context
pdf, 123kb -
Vaccines and associated regulatory issues relevant in the pandemic context
pdf, 257kb -
PaniFlow tool for monitoring drug/vaccine adverse events during a pandemic
pdf, 100kb -
Blood supply and blood products: regulatory issues in the pandemic context
pdf, 900kb -
Potential Use of Convalescent Plasma During a Flu Pandemic
pdf, 167kb
Workshop D - Regulatory Approaches to Proving Interchangeability
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Proof of interchangeability of pharmaceutical products and assurance of their quality in Ukraine
pdf, 1.44Mb -
Implementation of bioequivalence requirements: lessons learned
pdf, 107kb -
Interchangeability and registration of multisource (generic) products in Japan
pdf, 297kb -
WHO biowaiver guideline in regulatory practice
pdf, 278kb
Plenary 3 - Building Mutual trust as a Key to Access
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WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property: Implications for Regulators
pdf, 137kb -
How to benefit from other regulators? A New Zealand view point
pdf, 177kb -
Buildign trust, enhancing competence among African Medicines Regulatory Authorities: a WHO initiative
pdf, 76kb
Plenary 4 - Regulatory systems in a Changing Environment
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Changing environments and small regulatory authorities
pdf, 2.83Mb -
Implications of rapid socioeconomic changes to the regulatory affairs
pdf, 217kb -
Changing environment and drug regulation. A viewpoint from Sweden
pdf, 31kb -
Regulatory paradigms for change: A Singapore perspective
pdf, 555kb -
Regulatory Systems: Dutch viewpoint
pdf, 1.62Mb
Workshop E - Strategies to Fight Counterfeit Medicines
Workshop F - Emerging Regulatory Issues Concerning Biosimilars and Biologicals
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Regulation of copies of therapeutic biological medicinal products: WHO guidelines
pdf, 127kb -
Regulatory considerations in Thailand
pdf, 137kb -
WHO guideline abbreviated licensing pathways biological products
pdf, 97kb
Workshop G - Emerging Diseases: Regulating Blood Products
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Overview Workshop G
pdf, 32kb -
Introduction Workshop G
pdf, 23kb -
Emerging diseases, blood safety and supply: Chikungunya virus outbreak
pdf, 1.45Mb -
Dengue outbreaks in Latin America
pdf, 7.13Mb -
Assessment criteria for blood regulatory systems: effectiveness in risk management
pdf, 79kb -
Plasma Quality: How does it matter?
pdf, 966kb -
Development of assessment tools
pdf, 404kb
Workshop H - Regulators' Contribution to Access
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Availability of human medicinal products in Europe - how big is the problem and what can we do? View from the regulator
pdf, 330kb -
Can regulators facilitate access: a viewpoint from China
pdf, 81kb
Workshop I - Update on Harmonization Initiatives
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Development of ICH Global Cooperation Group: a non-ICH regional harmonization and country perspective
pdf, 741kb -
Harmonization of drug regulation in East Africa: the way forward
pdf, 133kb -
Harmonization of regulatory requirements: a view point from an APEC country
pdf, 362kb -
Update on Pan American Network for Drug Regulatory Harmonization (PANDRH)
pdf, 434kb
Workshop J - Role of Regulators in Clinical Trial Approval
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Registration of clinical trials in the national registry or authorization by the national DRA - what should come first?
pdf, 435kb -
Roles and responsibilities of national regulators and the Ethics Committees: ways for better cooperation and communication
pdf, 275kb -
Interactions between manufacturing and trial host country regulators
pdf, 108kb
Workshop K - Building Regulatory Capacity: Best Practices for the Future
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Building regulatory capacity
pdf, 1.02Mb -
NRA assessment/benchmark system and institutional development plan (IDP)
pdf, 1.34Mb -
Building regulatory capacity in a regulatory network: experience from Twinning projects and EU worksharing
pdf, 731kb
Workshop L - GMP Inspections: Impact of Information Sharing and Risk Management
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Introductory slides
pdf, 14kb -
Risk management of GMP inspections: Australian approach
pdf, 154kb -
Coping with increasing need for inspections: ASEAN initiatives
pdf, 472kb
Plenary 5 - Crisis Management: Safeguarding Health
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Mechanisms for information sharing and public health response under the International Health Regulations (IHR)
pdf, 336kb -
Communication during a crisis: nelfinavir case study
pdf, 63kb -
Nelfinavir: Where are we now? Experience in Barbados
pdf, 861kb -
Nelfinavir: Where are we now? Experience in Ghana
pdf, 172kb -
Responding to vaccine safety events
pdf, 187kb
Plenary 6 - Current Topics
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WHO Good Governance for Medicines programme: the Zambian experience
pdf, 176kb -
New proposal for EU Variation Regulation - point of view of an EU National Competent Authority
pdf, 265kb -
Challenges in regulating radiopharmaceuticals: view of the International Consultancy Group affiliated to IAE
pdf, 516kb -
Adverse reactions related to change of formulation: thyroxine case
pdf, 20kb -
Involving consumers in medicines surveillance reporting
pdf, 572kb -
Involving consumers in medicines surveillance
pdf, 383kb -
Revision of WHO stability testing guidelines
pdf, 97kb -
WHO Certification Scheme for Finished Pharmaceutical Products. Where are we today?
pdf, 390kb