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ICH                 Harmonization for Better HealthBenhur Pradeep                                          http://www.mycl...
Outline ICH Mission Need to Harmonize Initiation of ICH Structure Observers Organization Process of Harmonization...
The purpose of clinical research is to create knowledge needed to improve healthcare. Without such knowledge,      action...
ICH (April 1990) International conference on Harmonization It is a joint initiative involving regulators & industry as e...
Mission To make recommendations towards acheiving greater  harmonization in the interporetation and application of techni...
Need to Harmonize Realisation was driven by tragedies, such as that with thalidomide  in Europe in the 1960s. The 1960s ...
Initiation of ICH Harmonization of regulatory requirements was pioneered by  European Community (Now EU) Success acheive...
Evolution of ICH Two decades of success, attributed by scientific concensus & the  commitment between industry and regula...
Structure             Regulatory Body                                    Industry                 Ministry of             ...
Observers WHO, EFTA (European Free Trade Association), Canada, Austrila –  Non voting members IFPMA (International feder...
Organization               http://www.myclinicalresearchbook.blogspot.com
Steering Committee Governing body that overseas the harmonization activities Six co-sponsors has two seats on the SC  (E...
GCG & MedDRA Management Board Global Cooperation Group represents from 5 Regional  Harmonnizational Initatives (RHI‘s) AP...
Secretariat & Coordinators Secretariat located in Geneva, Switzerland, operating from IFPMA  offices Secretariat staff i...
ICH Working Groups Each party establishes a contact network of experts with in their  own organization or region in order...
Process of Harmonization ICH harmonization activities fall into 4 categories  - 1. Formal ICH Procedure: New topic for Ha...
Work Products 1. ICH Guidelines 2. MedDRA 3. CTD 4. Electronic Standards 5. Consideration Documents 6. Open Consulta...
The Guidelines – Q S E M Quality (Q1-Q11)  - chemical & Pharmaceutial QA Safety (S1-S10,M3)  - dealing with invitro & in...
Quality Q1-Stability Q2-Analytical Validation Q3-Impurities Q4-Pharmacopoeias Q5-Quality of Biotechnological Products...
Safety S1-Carcinogenicity Studies S2-Genotoxicity Studies S3-Toxicokinetics and Pharmacokinetics S4-Toxicity Testing ...
Efficacy E1&E2-Clinical Safety E3-Clinical Study Reports E4-Dose-Response Studies E5-Ethnic Factors E6-Good Clinical ...
Multidisciplinary M1-MedDRA Terminology M2-Electronic Standards M3-Non-clinical Safety Studies M4-CTD M5-Data element...
Conclusion ICH launched 20 years ago ICH brings together the drug regulatory authorities of  Europe, Japan, and the Unit...
Thank You                            Benhur Pradeep                            Pradeep.ben84@gmail.com                    ...
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  1. 1. ICH Harmonization for Better HealthBenhur Pradeep http://www.myclinicalresearchbook.blogspot.com
  2. 2. Outline ICH Mission Need to Harmonize Initiation of ICH Structure Observers Organization Process of Harmonization Work Products The Guidelines – Q S E M http://www.myclinicalresearchbook.blogspot.com
  3. 3. The purpose of clinical research is to create knowledge needed to improve healthcare. Without such knowledge, action for healthcare may be impossible, wasteful, expensive or harmful because it will have no logical or empirical basis. http://www.myclinicalresearchbook.blogspot.com
  4. 4. ICH (April 1990) International conference on Harmonization It is a joint initiative involving regulators & industry as equal partners in the scientific & technical discussions of the testing procedures which are required to ensure and assess the safety, quality & efficacy of medicines. http://www.myclinicalresearchbook.blogspot.com
  5. 5. Mission To make recommendations towards acheiving greater harmonization in the interporetation and application of technical guidelines and requirements for pharmaceutical product registration, there by reducing duplicating of testing carries out during the research & development of new human medicines. http://www.myclinicalresearchbook.blogspot.com
  6. 6. Need to Harmonize Realisation was driven by tragedies, such as that with thalidomide in Europe in the 1960s. 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. Divergence in technical requirements from country to country http://www.myclinicalresearchbook.blogspot.com
  7. 7. Initiation of ICH Harmonization of regulatory requirements was pioneered by European Community (Now EU) Success acheived by Europe demonstrated that harmonization was possible At same time there were bilateral discussions between Europe, Japan & US, on possibilites for harmonization The birth of ICH took place at meeting in April 1990 in Brussels Topics selected for harmonization – - SAFETY - QUALITY & - EFFICACY http://www.myclinicalresearchbook.blogspot.com
  8. 8. Evolution of ICH Two decades of success, attributed by scientific concensus & the commitment between industry and regulatory parties. First decade saw significant progress in the development of tripartitie ICH guidelines on SAFETY, QUALITY & EFFICACY topics and also on Multidisciplanary topics (MedDRA, CTD) Expanded communication & dessemination of information on ICH guidelines with Non-ICH regions Estb. Global Cooperation Group (GCG) – in response to a growing interest from beyond the ICH region in the use of ICH guidelines http://www.myclinicalresearchbook.blogspot.com
  9. 9. Structure Regulatory Body Industry Ministry of European US Food & Pharmaceutical Health, Labo Federation of Japan Research &European Drug Pharmaceutical Pharmaceutical r and Industries Association ManufacturesUnion (EU) Administrati of America Welfare, Jap Associations (JPMA) on (US-FDA) (PhRMA) an (MHLW) (EFPIA) http://www.myclinicalresearchbook.blogspot.com
  10. 10. Observers WHO, EFTA (European Free Trade Association), Canada, Austrila – Non voting members IFPMA (International federations of Pharmaceutical Manufactures Association) representative http://www.myclinicalresearchbook.blogspot.com
  11. 11. Organization http://www.myclinicalresearchbook.blogspot.com
  12. 12. Steering Committee Governing body that overseas the harmonization activities Six co-sponsors has two seats on the SC (EU, EFPIA, MHLW, JPMA, USFDA, PhRMA) 3 Observers are WHO, Health Canada, European Free Trade Association (EFTA) The IFPMA host the ICH secretarist & participartes as a non-voting member http://www.myclinicalresearchbook.blogspot.com
  13. 13. GCG & MedDRA Management Board Global Cooperation Group represents from 5 Regional Harmonnizational Initatives (RHI‘s) APEC, ASEAN, EAC, GCC, PANDRH, SADC MedDRA mngt. Board:- Overall responsibility for direction of MedDRA. MedDRA an ICH stansardised dictonary of medical terminology The board oversees the activites of MedDRA “Maintenance and Support Services“ (MSSO) which serves as the repository, maintainer, developer and distributor of MedDRA http://www.myclinicalresearchbook.blogspot.com
  14. 14. Secretariat & Coordinators Secretariat located in Geneva, Switzerland, operating from IFPMA offices Secretariat staff is responsible for day to day management of ICH, namely preparations for & documentation of, meetings of the SC and its working group Coordinators: fundamental to the smooth running of ICH http://www.myclinicalresearchbook.blogspot.com
  15. 15. ICH Working Groups Each party establishes a contact network of experts with in their own organization or region in order to ensure that, in the discussions they reflect the views & policies of the co-sponsor they represent There are several different types of ICH working groups - EWG: Expert Working Group - IWG: Implementation Working Group - Informal Working Group - Discussion Group http://www.myclinicalresearchbook.blogspot.com
  16. 16. Process of Harmonization ICH harmonization activities fall into 4 categories - 1. Formal ICH Procedure: New topic for Harmonization - 2. Q&A Procedure: Clarification on existing guideline - 3. Revision Procedure - 4. Maintenance Procedure http://www.myclinicalresearchbook.blogspot.com
  17. 17. Work Products 1. ICH Guidelines 2. MedDRA 3. CTD 4. Electronic Standards 5. Consideration Documents 6. Open Consultations http://www.myclinicalresearchbook.blogspot.com
  18. 18. The Guidelines – Q S E M Quality (Q1-Q11) - chemical & Pharmaceutial QA Safety (S1-S10,M3) - dealing with invitro & invivo preclinical testing Efficacy (E1-E16, Except E13) - clinical studies in human beings Multidiscilplinary (M1-M8) - terminology, electronic standards, common documents http://www.myclinicalresearchbook.blogspot.com
  19. 19. Quality Q1-Stability Q2-Analytical Validation Q3-Impurities Q4-Pharmacopoeias Q5-Quality of Biotechnological Products Q6-Specifications Q7-Good Manufacturing Practice Q8-Pharmaceutical Development Q9-Quality Risk Management Q10-Pharmaceutical Quality System http://www.myclinicalresearchbook.blogspot.com
  20. 20. Safety S1-Carcinogenicity Studies S2-Genotoxicity Studies S3-Toxicokinetics and Pharmacokinetics S4-Toxicity Testing S5-Reproductive Toxicology S6-Biotechnological Products S7-Pharmacology Studies S8-Immunotoxicology Studies S9-Nonclinical evaluation for anticancer pharmaceuticals S10-Photosafety Evaluation http://www.myclinicalresearchbook.blogspot.com
  21. 21. Efficacy E1&E2-Clinical Safety E3-Clinical Study Reports E4-Dose-Response Studies E5-Ethnic Factors E6-Good Clinical Practice E7,E8,E9,E10&E11-Clinical Trials E12-Guidelines for Clinical Evaluation by Therapeutic Category E14-Clinical Evaluation E15&E16-Pharmacogenomics http://www.myclinicalresearchbook.blogspot.com
  22. 22. Multidisciplinary M1-MedDRA Terminology M2-Electronic Standards M3-Non-clinical Safety Studies M4-CTD M5-Data elements & Standards for Drug dictonaries M6-Gene Theraphy M7-Genotoxic Impurities M8-eCTD http://www.myclinicalresearchbook.blogspot.com
  23. 23. Conclusion ICH launched 20 years ago ICH brings together the drug regulatory authorities of Europe, Japan, and the United States, along with the pharmaceutical trade associations from these three regions, to discuss scientific and technical aspects of product registration. It is ICH’s mission to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration, thereby reducing duplication of testing and reporting carried out during the research and development of new medicines. http://www.myclinicalresearchbook.blogspot.com
  24. 24. Thank You Benhur Pradeep Pradeep.ben84@gmail.com http://www.myclinicalresearchbook.blogspot.comwww.presentationpoint.com
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