Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
The New Drugs and Clinical Trials (Amendment) Rules, 2023. ClinosolIndia
The latest rules for the registry of Clinical Research Organisations (CRO) in India were issued in The New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.
The registration process requires the CRO to submit an application with all the necessary details about the clinical trial or study, including the name and address of the sponsor, the name and qualifications of the principal investigator, details of the investigational drug, and other relevant information.
Once the application is submitted, the Central Licensing Authority will examine it to ensure that all necessary information has been provided and that the CRO has the necessary infrastructure, personnel, and equipment to conduct the study safely and effectively. If the Authority is satisfied with the application, it will grant registration to the CRO, after which it can conduct the clinical trial or study as per the approved protocol.
These rules are a significant step forward in ensuring the safety and ethical conduct of clinical trials and studies in India, and in providing greater accountability and transparency in the research process.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
Approaches to regulatory approval and process validation often must be quite different than traditional approaches. This presentation walks through nine approaches that might be helpful to your project.
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
The New Drugs and Clinical Trials (Amendment) Rules, 2023. ClinosolIndia
The latest rules for the registry of Clinical Research Organisations (CRO) in India were issued in The New Drugs and Clinical Trials (Amendment) Rules, 2023. These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.
The registration process requires the CRO to submit an application with all the necessary details about the clinical trial or study, including the name and address of the sponsor, the name and qualifications of the principal investigator, details of the investigational drug, and other relevant information.
Once the application is submitted, the Central Licensing Authority will examine it to ensure that all necessary information has been provided and that the CRO has the necessary infrastructure, personnel, and equipment to conduct the study safely and effectively. If the Authority is satisfied with the application, it will grant registration to the CRO, after which it can conduct the clinical trial or study as per the approved protocol.
These rules are a significant step forward in ensuring the safety and ethical conduct of clinical trials and studies in India, and in providing greater accountability and transparency in the research process.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
Approaches to regulatory approval and process validation often must be quite different than traditional approaches. This presentation walks through nine approaches that might be helpful to your project.
Strategies to Increase Medical Affairs' Role in Health Outcomes Data Generati...Best Practices
With the shift toward evidence-based medicine and value-based pricing, many bio-pharmaceutical companies are transitioning their Health Economics and Outcomes Research (HEOR) function away from the Commercial organization to Medical Affairs. This has some major implications towards the interactions with key stakeholders, the way interactions are documented and the skill sets & activities that may be required. Development of strong health outcomes capabilities within Medical Affairs organizations requires an increase in that function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data by stakeholders and building real world data capabilities to generate and utilize health outcomes information.
Best Practices, LLC undertook this study to identify strategies to increase MA’s role in Health Outcomes data generation and utilization. Specifically, the study highlights the role of Medical Affairs function in HO activities, industry drivers and resource levels for HO groups, challenges of MA’s involvement in HO activities and strategies for effective HO data communication and utilization.
Download Full Report: http://bit.ly/2dGFAbz
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
GLOBAL SUBMISSION OF IND, NDA, ANDA.pdfLokeshThakre6
It's important to note that the specific requirements and processes for INDs, NDAs, and ANDAs may vary between regulatory authorities in different countries. The descriptions provided here are general and based on the common practices in the United States.
This Slide explains US-FDA requirements for IND. It will answer; What is an IND ?What are the IND Phases ?What is the IND Content?When FDA Terminates an IND ?Are cGMP Required for IND ?What Studies are exempt from IND?
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
2. What is a fast track process.
Other similar Expedited programs of FDA
History of Fast track development process
Features of Fast track designation
Approval process of Fast track designation
Withdrawal of a drug from Fast Track designation.
Conclusion
References
3. Fast Track Drug Development is a process
that is designed to accelerate the development
and review of drugs to treat serious conditions
and fill an unmet medical need.
The purpose fast track drugs is to get
important new drugs to the patient earlier.
4. 1. BREAKTHROUGH THERAPY DESIGNATION : It
is a process designed to accelerate the
development and review of drugs which may show
substantial improvement over the current therapy.
2.ACCLERATED APPROVAL : These regulations allow
the drugs for serious conditions to get approved
based on surrogate endpoint.
3.PRIORITY REVIEW DESIGNATION : A priority
review designation means FDA’s goal is to take
action on approval of application within six months.
Other similar Expeditedstudies under FDAprogram :
5. In 1997, FDA’s ModernizationAct directed the FDA
to create a system so that the important new drugs
could reach patients even more quickly.
Thus, then Fast track program was introduced as
fast track designation under section 506(b) of
Food, Drug and Cosmetic Act.
Under this section, FDA may grant approval to
Drug as Fast track designation if two criteria's are
Fulfilled :
6. (a) Serious Condition.
(b) Potential to fulfil the unmet medical need.
Features of Fast track Designation
(a).Expedite Development and Review : Once the
FDA receives a Fast track request, early and
frequently interaction with the review team is
encouraged.
These include meetings with FDA team including
Pre-IND meetings, Design study, Dose response
concerns and use of Bio markers.
7. (b).Rolling review : It means that the Drug company
can submit the filled or completed section of its New
Drug Application to FDA rather than waiting until
every section of its New Drug Application gets
completed.
(c).Ability to address emerging public health need :
Drugs under Fast track designation can be approved
or passed more quickly which may benefit the patient
as the time for drug availability will be less.
(d).Showing superior effect and therapeutic action
on serious and adverse outcomes.
8. Sending a Designation submission
Receiving the Fast Track Request
FDA Review and Response
Approval
9. 1. Sending a Designation Submission
• Sponsors may request FastTrack designation when the
INDA is first submitted or at any time thereafter before
receiving marketing approval of their NDA.
• Usually, FDA should receive the Fast track request no later
than pre-IND meeting with the Agency because once the
meeting is over, no other features of Fast track
Designation will be applied.
• If a sponsor’s drug development program is granted fast
track designation for one indication and has subsequently
obtained data to support fast track designation for another
indication, the sponsor should submit a separate request.
10. 2.Content of Designation Submission :
The request should contain the following information captured
in 15-20 pages and ‘REQUEST FOR FASTTRACK
DESIGNATION’ should be written on cover case in Bold letters :
The name of Sponsor’s contact person and the contact
details like telephone no. , address, email etc.
If applicable ,the Investigational New Drug Application
number should be mentioned.
For drug products, the proprietary name and active
ingredients and for Biological products, the proper name and
proprietary name should be given.
11. The name of Division or Office to which the IND has been
submitted.
Summary of Information that support Fast track
designation request which includes the following:
Information for considering the drug capability to address
the unmet medical need.
Information for considering the drug capability to treat a
serious condition
3. Receiving the Fast track request :
IND and related documents are received by the Appropriate
review division or by CDER.
12. 4. FDA Response :
FDA will respond to Fast track designation request
within 60 days and will issue Sponsor a Designation
letter or a Non-designation letter
Designation letter : If the agency is satisfied with
the submission of sponsor, they may issue a
designation letter.
Non-designation letter : If the agency was not
satisfied with the submission of sponsor, they may
issue a non designation letter.The reason may be
stated as drug failed to meet the criteria for Fast
track designation.
13. Withdrawal of Fast Track Designation
Over the years of drug development, it is expected that some
drugs which are granted Fast track designation will not meet
the Criteria for fast track later.
This may be due to reason that new and advanced drugs are
discovered and the Fast track drug no longer shows a active
potential to address unmet medical need.
If the sponsor recognizes that Fast track drug development
program will no longer be continued, same must be informed
to Agency.
The Agency then send a confirmation letter to the sponsor
indicating the end of his Fast track designation.
14. Fast Track Approved drugs
NDA
Reg. No.
Name of the Drug Applicant Approval
Date
Therapeutic Use
N22268 COARTEM NOVARTIS 4/07/2009 Malaria treatment
N22059 TYKERB GSK 26/2/2010 Over expressing
Breast Cancer
N21991 ZOLINZA MERCK 10/6/2006 T-cell lymphoma
treatment
N21937 ATRIPLA GILEAD
SCIENCES
7/12/2006 Treatment of HIV
N21882 EXJADE NOVARTIS 12/1/2004 Chronic Iron overdose
Treatment
N22041 CYANOKIT EMD 12/5/2006 Suspected cyanide
poisoning
Here are few examples of fast track drugs :
15. SUMMARY
Fast track designation is a process by which the drug for serious or life
threatening disease can be developed more rapidly and can be easily
delivered to the patients.
In order to get fast track approval, applicant sends a submission to
agency along with the NDA containing all required information of the
drug.
FDA issues a Designation letter or Non designation letter after review
and verification of details.
Many Fast track drugs are approved from time to time but they can be
recalled if they show adverse effect on patients.
Also, if sponsor feels that he no longer wants to continue fast track
program, he can inform it to Agency.
16. References:
• Reichert JM, Rachon SL, Zhang BD, A decade of Fast track
programs, International Journal of Expedite programmes
2008; 7(11):1-4
• Chary KV, Expedited drug review process: Fast but flawed,
Journal of Pharmacology and Pharmacotherapeutics 2016;
7(2): 57-61
• Shulman SR, Brown JS, Fast track approval program,
Journal of Applied Science and Medical Research 2015;
5(3): 6-10
• Henry Wilson, Expedited programs for serious conditions-
Drugs and Biologics, a textbook of guidance for Industry
2014; 5(2): 7-9, 28-33