NBScience,medical conferences,GCP trainings

Clinical Research Course has been established in order to develop an internationally accepted standard of knowledge and understanding of the research process and related regulations, as well as medical and scientific areas related to clinical research.

10.00 Introduction
10.15 -Estimating the savings in total costs of clinical trials

Dr. Werner Gielsdorf,Healthcare Services and Consulting (HSC),Germany
GCP, GLP, GDP, GMP trainer.
Project Manager of Tacis project,EU, World Bank, UNCTAD/WTO,
training Centre for GMP/GDP and GCP inspectors

Beata Drobniak, GCP trainer,CRDE, European Forum of GCP
12.15 -Informed Consent

Prof.Lizogub V.G.,Deputy Director of State Pharmacological center of Ministry of Health of Ukraine

Dr.Zadorin Yevgen, PhD,MBA ,Member of European Forum of GCP ,International Biopharmaceutical Association

Session Descriptions
Clinical Pharmacology and AE Reporting - Understanding the presentation and detection of adverse drug events, the pharmacodynamic and pharmacokinetic mechanisms of reactions, methods of causality assessment, safe medication practices in clinical research, and the FDA’s Risk Management Program.

Development and the Research Budget - Review of (drug, device, biologics) development program, including protocol development, Case Report Form design, project and program management, assessing costs and building budgets. How to develop budgets and strategies for reducing costs (at the investigational site).

Drug Development Process - Review and discussion regarding the definitions, regulations and processes from IND to NDA. This session includes Regulatory Affairs and IRBs (IND/NDA) - Review of federal regulations, IRB guidelines, written procedures, and record keeping requirements for clinical trials management.

ICH Guidelines - Discussion about the development and implementation of the International Committee on Harmonization, the clinical research guidelines resulting from that collaboration, and how the ICH Guidelines affect the clinical Researcher.

IRBs and the Informed Consent Process - Discussion of regulations, generally accepted policies and procedures, and audit practices associated with IRBs and the informed consent process.
Preparing for an FDA Audit - Perspectives and regulations regarding adherence to protocol, patient rights, informed consents, and regulatory issues related to an FDA audit.

Research Ethics - The importance of the informed consent and the principles of medical research ethics are discussed as well as therapeutic misconceptions, randomizations, and placebos. This session includes Regulatory Affairs and IRBs (IND/NDA) - Review of federal regulations, IRB guidelines, written procedures, and record keeping requirements for clinical trials management.
Source Documentation and Administration - Review of procedural and management issues regarding utilization and disposition of source documents.

Epidemiological and Statistical Issues - The study of the distribution and determinants of health related events in certain populations.

Genetics and Pharmacogenetics - A review of the development and science supporting these interventions.

Research Ethics - The importance of the informed consent and the principles of medical research ethics are discussed as well as therapeutic misconceptions, randomizations, and placebos.

History and Future of ICH

The Need to Harmonise

The history of medicinal product registration, in much of the industrialised world, has followed a similar pattern which could be described as: Initiation, Acceleration, Rationalisation and Harmonisation.

The realisation that it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions. In the United States a tragic mistake in the formulation of a children's syrup in the 1930s was the trigger for setting up the product authorisation system under the Food and Drug Administration. In Japan, government regulations requiring all medicinal products to be registered for sale started in the 1950s. In many countries in Europe the trigger was the thalidomide tragedy of the 1960s, which revealed that the new generation of synthetic drugs, which were revolutionising medicine at the time, had the potential to harm as well as heal.

For most countries, whether or not they had initiated product registration controls earlier, the 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products. The industry, at the time, was becoming more international and seeking new global markets, but the registration of medicines remained a national responsibility. Although different regulatory systems were based on the same fundamental obligations to evaluate the quality, safety and efficacy, the detailed technical requirements had diverged over time to such an extent that industry found it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products, internationally.

The urgent need to rationalise and harmonise regulation was impelled by concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.

Initiation of ICH

Harmonisation of regulatory requirements was pioneered by the European Community, in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible. At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonisation. It was, however, at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, that specific plans for action began to materialise. Soon afterwards, the authorities approached IFPMA to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived.

The birth of ICH took place at a meeting in April 1990, hosted by the EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the USA met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.

The Early Meetings

At the first SC meeting of ICH the Terms of Reference were agreed and it was decided that the Topics selected for harmonisation would be divided into Safety, Quality and Efficacy to reflect the three criteria which are the basis for approving and authorising new medicinal products. Eleven such Topics were selected for discussion at the First International Conference on Harmonisation.

The "pattern" of ICH work was also established in those early Steering Committee meetings, that is, that the EWGs meet in the same week as the Steering Committee and report on their progress to the Committee.

Commitment and Process

Key factors in the success of ICH have been the commitment of the parties to the objectives and outcome of ICH and the development of the "ICH Process" for developing harmonised guidance on technical issues. The commitment to ICH was set out in a Steering Committee Statement from the meeting in Tokyo, October 1990.

The ICH "Process" was first drawn up at the Steering Committee meeting in Washington, March 1992 and amended in Tokyo, September 1992. The defined process with "decision points" at Step 2 and Step 4 has enabled the Steering Committee to monitor the progress of the topics selected for harmonisation.

STATEMENT BY THE ICH STEERING COMMITTEE TOKYO, OCTOBER 1990

The Parties cosponsoring this Conference, represented at the 2nd Steering Committee Meeting in Tokyo, 23-24 October 1990 re-affirmed their commitment to increased international harmonisation, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner. These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimise the use of animal testing without compromising the regulatory obligations of safety and effectiveness.

This Conference will provide a unique opportunity for regulators and industry to reach consensus on the steps needed to achieve this objective through greater harmonisation of technical requirements and to set out practical and realistic targets for harmonising requirements where significant obstacles to drug development and the regulatory process have been identified.

Recognising the substantial progress which has already been made in achieving harmonisation within Europe and through bilateral contacts between Europe, Japan, USA and other regions, the Conference will seek to make further progress through a trilateral approach, with clearly defined priorities, methods of work and recommendations to both industry and regulatory authorities.

Whilst the Conference will be an important step forward, it is not seen as an end in itself, but as a stage in a developing process, at a high level, between regulators and industry.

The Conference, its preparations and follow-up activities will be conducted in an open and transparent manner and the presence of observers from other regulatory authorities and WHO is welcomed as a means of ensuring that the benefits of progress towards harmonisation can be utilised world-wide.
The Conference will not only look at existing issues but will, based on past experience, seek to minimise future divergence of new registration requirements, as a consequence of technical progress.

Format of Applications

The Steering Committee has given priority to harmonising the technical content of the sections of the reporting data where significant differences have been identified between regulatory requirements across the three regions: Europe, Japan and the USA. The first ICH Guideline to deal with harmonising the format of reporting data was E3, Content and Format of Clinical Study Reports. This Guideline describes a single format for reporting the core clinical studies that make up the clinical section of a registration dossier.

A target for the first phase of ICH activities was to remove redundancy and duplication in the development and review process, such that a single set of data could be generated to demonstrate the quality, safety and efficacy of a new medicinal product.The long-term goal of developing a harmonised format has led to the creation of the ICH Guideline M4, The Common Technical Document (CTD). The CTD provides a harmonised format and content for new product applications. ICH achieved Step 4 status of the CTD at the ICH5 Conference in San Diego, California, in November 2000. The agreed upon implementation date for the CTD, in the three regions, was July 2003.

The Electronic Common Technical Document (eCTD) was developed subsequently by the M2 Expert Working Group. This specification document allows for the electronic submission of the CTD from applicant to regulator and provides a harmonised technical solution to implementing the CTD electronically. The eCTD has begun to be implemented across the ICH partner and observer regions.

The Future of ICH - Revised 2000

Statement by the ICH Steering Committee on the occasion of the Fifth International Conference on Harmonisation, 9-11 November 2000, San Diego

The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in Europe, Japan and the United States, in order to make these products available to patients with a minimum of delay.

The six parties to ICH represent the regulatory bodies and research-based industry in the three regions, Europe, Japan and the USA, where the vast majority of new medicines are currently developed.

The ICH process has achieved success because it is based on scientific consensus developed between industry and regulatory experts and because of the commitment of the regulatory parties to implement the ICH tripartite, harmonised guidelines and recommendations.

The Fifth International Conference on Harmonisation (ICH 5) San Diego, November 2000, marks the end of 10 years of activity thus providing an opportunity to evaluate results and to identify future needs in the area of international harmonisation.

Continuation of harmonisation activities

The ICH Steering Committee and other interested parties have agreed to continue in their commitment to pursue future harmonisation activities.

ICH has been successful in achieving harmonisation, initially of technical guidelines and more recently on the format and content of registration applications. All parties agree that there is a need to maintain this harmonisation in the interest of the patient and public health to prevent unnecessary duplication without compromising the regulatory obligations of safety, quality and efficacy. New approaches to the maintenance of the products of harmonisation is needed. In addition, further harmonisation activities should be continued in a focused manner.

Steering Committee structure and participation

The existing Steering Committee structure continues to be appropriate. In the interests of greater transparency, the Steering Committee, however, welcomes the appropriate participation of other interested parties in a flexible and ad hoc manner on topics which affect them.

The Steering Committee continues to believe that regular large conferences help to communicate the results of the harmonisation activities to the widest possible audience.

Global co-operation

The recent emphasis on global co-operation actions by ICH acknowledges the important role of WHO in disseminating information and providing input beyond the ICH regions. The Steering Committee recognizes the need to expand its communication and dissemination of information with non-ICH parties. A more active involvement of WHO through its regional centres is welcomed.

New ways of working together

There is a need to explore alternate approaches to the traditional ICH model of expert working groups (EWGs), particularly in areas where constantly changing scientific information has been identified. The possibility of making better use of techniques such as videoconferencing and electronic communication can only serve to enhance the communication between the ICH parties, as well as with other involved parties.

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