Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999: Need for Bioequivalence

Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages)

Table of Contents

	Opening Ceremony
		Ms Andrea Fischer, Federal Minister for Health, Germany
		Dr Michael Scholtz, Health Technology and Pharmaceuticals World Health Organization
		Professor Alfred C. Hildebrandt, Federal Institute for Drugs and Medical Devices, Germany
	Good regulatory practice
		National challenges: pharmaceutical sector reform
		Regional approaches to regulation in Europe
		Recommendations
	Good certification practice
		Recommendations
	Counterfeit drugs: challenges and solutions
		Illicit pharmaceutical markets
		The situation of counterfeit drugs
		Recommendations
	Current issues in regulation and quality
		Enforcement of regulatory functions
		Quality of starting materials and the role of pharmacopoeias
		Implementation of good manufacturing practices
		Upgrade of local production
		Recommendations
	International Conference on Harmonization: implementation and implications
		Introduction to the ICH
		Non-ICH country perspective: Egypt
		Non-ICH country perspective: Australia
		Recommendations
	Drug utilization studies
		Methodology of drug utilization studies
		Experience of ATC/DDD in Tunisia
		Experience in the Netherlands
		Recommendations
	International Conference on Harmonization and the common technical document
		Non-ICH country perspective: Switzerland
		The ICH common technical document (CTD)
		Summary
	Keynote address
		Dr Gro Harlem Brundtland, Director-General, World Health Organization
	Global and national efforts to reduce tobacco use
		How national authorities can promote non-smoking: experience from a European Union country
		International implications of the regulation of nicotine products
		Public health responsibilities of nicotine regulation
		Discussion
		Recommendations
	Electronic communication in the regulatory process
		Networking of drug regulatory authorities: CADREAC
		Computer-assisted Drug Registration
		Recommendations
	Transparency in monitoring the safety of medicines
		Signal generation
		Safety issues - lessons learnt
		Response to a drug alert situation
		Principles of risk communication
		Existing mechanisms of information exchange
		Recommendations
	Pharmaceutical products for use in special groups
		Current situation and approaches: Dr E. Esber, USA Future trends: Dr S. Martindale, New Zealand Developing country needs: Dr E. Kkolos, Cyprus, Dr R. Omotayo, Nigeria, and Dr Nguyen Van Tuu, Viet Nam
		Recommendations
	Need for Bioequivalence
		The rationale for bioequivalence studies
		Can in vitro replace in vivo studies?
		Application of requirements for in vivo studies
		Recommendations
	Antimicrobial resistance: battling the bugs
		Country experience in implementing antimicrobial resistance strategies
		Veterinary, aquaculture and agricultural use’ of antimicrobials contributing to resistance
		The role of regulators in the containment of resistance
		Recommendations
	Safety issues of plasma-derived medicinal products
		Regulatory experience in industrialized countries: USA
		Regulatory experience in industrialized countries: Germany
		Regulatory experience in countries with evolving plasma-fractionation facilities
		Regulatory experience in countries with no production of plasma-derived products: Malaysia
		Regulatory experience in countries with no production of plasma-derived products: Zimbabwe
		Recommendations
	Herbal medicines
		Regulation of traditional Chinese medicines
		Regulation of herbal medicines in the European Union
		Guidelines for evaluating herbal medicines
		Regulation of complementary medicines
		Recommendations
	Regulation and access to essential drugs
		Pricing policy and regulation
		Regulation and community drug programmes
		Availability of essential drugs during an economic crisis
		Classification of drugs
		The role of the drug regulatory authority in drug donation
		The role of the regulatory authority in improving access to drugs
		Recommendations
	Participants
	Back cover

Need for Bioequivalence

Moderators: Dr P Bazerque, Argentina, and Mr T. Slater, Australia