ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
European medicine agency is one of the finest agency to check the quality, efficacy ,safety of a drug in all European countries . It consists of 27 states of Europe as its member.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
European medicine agency is one of the finest agency to check the quality, efficacy ,safety of a drug in all European countries . It consists of 27 states of Europe as its member.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE
ICH and ICH guidelines
Need
Origin of ICH
Evolution of ICH
ICH members
Steps of ICH
STEP 1: Building Scientific Consensus
STEP 2: Agreeing on Draft Text
STEP 3: Consulting Regional Regulatory Agencies
STEP 4: Adopting Harmonized Guidelines
STEP 5: Implementing Guidelines in ICH Regions
Categories of ICH guidelines
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
1.5 international conference on harmonizationShital Patil
ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
2. FLOW OF PRESENTATION
• What is ICH
• Object of ICH
• History
• Organization of ICH
• STEPS IN ICH PROCESS
• GUIDELINES
• BENEFIT OF ICH
• Conclusion
3. What is ICH ?
International Council for Harmonizsation
ICH is a joint initiative involving both regulator
& research- based industry of the EU, Japan and
the US in scientific and technical discussion of
the testing procedures which are required to
ensure and assess the safety, quality & efficacy of
medicines.
4. Objective of ICH
• To increase international harmonization of technical
requirements to ensure that safe , effective, high
quality medicines are developed.
• To harmonize technical requirements for registration
or marketing approval.
• To promote public health.
• To prevent unnecessary duplication of clinical trials
on humans.
• To minimize the use of animal testing without
compromising safety and effectiveness of drug.
5. History
Need to harmonize ?
Industry becoming global
Duplicate test procedure
• Time consuming
• Expensive
Increasing R & D costs
Meeting public demand
6. History cnontd …
• Initiation of ICH
1980 :- European community
1989 :- WHO conference on Drug Rehulatory
Authorities, Paris
1990 :- Birth of ICH, meeting in Brussels
• Europe
• Japan
• US
Topics for harmonization divided into :
safety,efficacy and quality.
7. Evolution of ICH
• 1990:- ICH
• 1999 :- GCG
• 2004 :- RHI
• 2008 :- Expanded GCG
• Note : - In 2015 International Conference on
Harmonization changed its name to the International
Council for Harmonization while becoming a legal entity
in Switzerland.
• On 23 October 2015 ICH conducted the initial meeting
of their new assembly.
8.
9. The Steering Committee
• The Steering Committee, made of six ICH Parties, governs the
ICH, determining the policies and procedures, selecting topics
for harmonization and monitoring progress of harmonization
initiatives. The ICH consists of:
I. European Commission
II. European Federation of Pharmaceutical Industries and
Associations (EFPIA)
III. Ministry of Health, Labour and Welfare (Japan) (MHLW)
IV. Japan Pharmaceutical Manufacturers Association (JPMA)
V. Food and Drug Administration (FDA)
VI. Pharmaceutical Research and Manufacturers of
America (PhRMA)
10. ICH Coordinators
• The coordinators are fundamental to the smooth running of the
ICH and are nominated by each of the six parties
• An ICH Coordinator act as the main contact point with the ICH
Secretariat
ICH Secretariat
The secretariat is primarily concerned with preparations for, and
documentation of ,meetings of the Steering committee as well as
coordination of, preparation for working group and discussion Group
meetings. Information on ICH Guidelines and the general ICH process
can be obtained from the ICH Secretariat
11. ICH Working Group
• Depending on the type of harmonization activity
needed, the steering committee will endorse the
establishment of one of three types of working
group i.e. Expert working group,
Implementation working group, informal
working group
12. Step in the ICH Process
• Step 1 : Drafts are prepared and circulated through
many revision until a “final harmonised draft ” is
completed.
• Step 2 : this draft is signed by the EWG as the agreed
upon draft and forwarded to the steering committee
for signing which signifies acceptance for
consultation by each of the six co-sponsors.
• Step 3 : the three regulatory sponsors initiate their
normal consultation process to receive comment.
13. step 4 : is reached when the steering committee
agrees that there is sufficient scientific consensus on
the technical issues. this endorsement is based on
the signatures from the three regulatory parties to
ICH affirming that the guideline is recommended for
adoption by the regulatory bodies of three regions.
step 5 : The process is complete when the guidelines
are incorporated into national or regional internal
procedure.
15. Quality Guidlines
• QUALITY : - those relating to chemical and
pharmaceutical quality assurance(stability testing,
impurity testing etc)
16. Q1A-Q1F STABILITY TESTING
• Q1A :- Stability testing of new drug substance and product.
• Q1B :- Photostability testing of new drug substance
and product.
• Q1C :- Stabilty testing for new dosage forms
• Q1D :- Bracketing and matrixing design for stability
test of new drug
• Q1E :- Evaluation of stability data
• Q1F :- Stability data package for registration and
application in climate zone 3rd & 4th
17. Safety Guidelines
• Those relating to in vitro and in vivo pre clinical
studies(carcinogenicity test , Genotoxicity test)
• S1 – Carcinogenicity studies
• S2 – Genotoxicity studies
• S3- toxicokinetics and pharmacokinetics
• S4-toxicity testing
• S5-reproductive toxicology
• S6-biotechnological product
• S7-pharmacology studies
• S8-immunotoxicology studies
• S9-nonclinical evaluation for anticancer pharmaceuticals
• S10-photosafety evaluation
18. Efficacy Guidelines
• Those relating to clinical studies in human subject
(Dose Response studies , good clinical practices)
• E1 & E2-Clinical safety
• E3-Clinical study report
• E4-Dose response studies
• E5- Ethnic Factor
• 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
19. Multidisciplinary Guidelines
• cross-cutting which do not fit uniquely into one of
the above categories
M1-MedDRA Terminolgy
M2-Electronic standards
M3-Non-clinical safety studies
M4-CTD
M5-Data elements & standards for drug dictonaries
M6-Gene theraphy
M7-Genotoxic imourities
M8-eCTD
20. Benefits of ICH
• Streamline R&D Process
• Rapid access to new medicine
• Reference and education material for non ICH
Members
• Implication in developing countries
• Benefits for regulator
• More then 50 harmonized guidelines
21. conclusion
• Ich launched 20 years ago
• Ich bring togeather the drug regulatory authrities of
europe, japan and the US, along with the
pharmacutical 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 requirement for product registration ,
thereby reducing duplication of testing and reporting
carried out during the research and development of
any medicines.
