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ICH
1. ICH
Harmonization for Better Health
Benhur Pradeep
http://www.myclinicalresearchbook.blogspot.com
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. 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. 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. 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. 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
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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
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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
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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
Manufactures
Union (EU) Administrati of America
Welfare, Jap Associations (JPMA)
on (US-FDA) (PhRMA)
an (MHLW) (EFPIA)
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10. Observers
WHO, EFTA (European Free Trade Association), Canada, Austrila –
Non voting members
IFPMA (International federations of Pharmaceutical Manufactures
Association) representative
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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
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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
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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
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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
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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
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17. Work Products
1. ICH Guidelines
2. MedDRA
3. CTD
4. Electronic Standards
5. Consideration Documents
6. Open Consultations
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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
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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
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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. Thank You
Benhur Pradeep
Pradeep.ben84@gmail.com
http://www.myclinicalresearchbook.blogspot.com
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