A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
- 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.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
- 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.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
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.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Model Attribute Check Company Auto PropertyCeline George
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Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
1. ICH GUIDELINE –Q,S,E,M
PRESENTED BY:
MISS SYEDA HASSAN YAMEEN
ROLL NO.170720886008
Subject: Regulatory affairs.
UNDER THE GUIDANCE OF:
DR. ABDUL MANNAN
M.PHARM,Ph.D
DEPARTMENT:PHARMACEUTICS.
1
DECCAN SCHOOL OF PHARMACY
Dar-us salam, Aghapura, Hyderabad.-504001
3. ICH is a joint organization in bringing together regulatory
authority and pharmaceutical industry to discuss scientific
and technical aspects of pharmaceuticals and develop ICH
Guidelines.
OBJECTIVE:
3
4. INITIATION OF ICH:
Inception -1990
Its been 30 years in 2020 since its inception.
ICH meeting was held in Singapore in NOV 19 and
20
It now has 17 members and 32 observers
4
5. WHY ICH IS FORMED?
MISSION:
To achieve greater harmonization worldwide to
ensure safe,effective high quality medicines are
developed ,registered and maintained in most
efficient manner meeting high quality standards.
5
10. AUDITORS:
• The responsibility of the Auditors is to audit (inspection of accounts)the financial
statements of the Association upon conclusion of each Final year.They should
ensure that the accounting of the Association complies with Swiss law .
10
11. ASSEMBLY:
• The ICH Assembly include all Members and Observers of the ICH Association.
11
13. MANAGEMENT COMMITTEE:
• The MC is responsible for submitting recommendations or proposals to the
Assembly in preparation of Assembly discussions.
13
14. ICH SECRETARIAT:
• The ICH Secretariat is responsible for day-to-day management of ICH,
coordinating ICH activities as well as providing support to the Assembly, the ICH
Management Committee and its Working Groups
14
19. QUALITY:IT is an attribute or property
characteristic that affect performance n
safety efficacy of drug .
Stability -defined as time lapse during
which the product retains the same
properties and characteristics that it
possessed at the time of
manufacture.the stability of the product
is expressed as shelf life.
19
20. Stability studies : are necessary to
evaluate instability due to physical
change (creaming of emulsion n caking of
suspension,loss of volatile
constituents,polymorphism ,color change
)microbiological changes, chemical
degradation of drug
under(hydrolysis,drug decomposition can
produce toxic products)
EX:P-AMINO SALICYLIC ACID( Tb)IS
CONVERTED TO P-AMINOPHENOL WHICH
IS TOXIC
20
21. Why stability studies are done:
• Assurance to the patient
• Legal requirement
• Economy wastage n establish reputation of the company
21
23. Stability testing methods:
REAL TIME ACCELERATED RETAINED SAMPLE CYCLIC TEMPERATURE
Product is stored
at longer
periods to
assess
degradation
under normal
storage
condition.
Product is
subjected to high
degree of stress
temperatures(40-
80) n humidity (30-
65%) for 6 months.
To detect the
amount of heat
required to
degrade the
product.
From Marketed
product atleast
one batch is
retained
Samples are
tested for eg:if
the product
actually has 5
years of shelf
life.
Cyclic
temperature
stress tests are
designed to
mimic
conditions in
market place
storage.The test
should have 20
cycles
23
24. ICH GUIDELINES
QUALITY:
QIA –Q1F :- Stability testing
Q2:-Analytical validation
Q3A-Q3E :- Impurities
Q4:-Pharmacopoeial harmonization
Q5:-Biotechnological products
Q 6:-Specification
Q7-Good manufacturing practices
Q8:-Pharmaceutical development of product
Q 9: -Quality risk management
QIo:-Pharmaceutical quality system
Q11 :-Development and manufacture of drug
substance 24
25. Q12 :-Lifecycle management
Q13 :-Manufacture of drug product and
drug substance
Q14 :-Analytical procedure
development.
25
26. • Drug safety studies may
include pharmacokinetics,
acute toxicity, repeat dose
toxicity, genotoxicity,
carcinogenesis, tumorigenicity,
and developmental and
reproductive toxicology
testing, toxicity to foetus .It is
the major aspect which
determine drug benefit risk
balance. drugs with high risk
profile should be avoided
unless needed 26
27. 27
• In the United States, most pharmaceuticals are tested
in animals for their carcinogenic potential before
widespread use in humans(pre clinical). Carcinogenicity
studies should be performed for any pharmaceutical
whose expected clinical use is continuous for at least 6
months(clinical) .
30. SAFETY:-
SIA-S1C:- carcinogenicity studies of pharmaceuticals
S2:- Genotoxicity studies
S3A:- toxicokinetic and pharmacokinetics studies
S3B: -Guidance for repeated dose tissue distribution
studies
S4 :-Chronic toxicity
S5 :-Reproductive toxicology
S6 :-Preclinical safety evaluation of biotechnology derived
productsntesting in animals(rodents)
S7A- S7B:-Safety pharmacology studies
S8 :-lmmunotoxicity studies for human
pharmaceuticals
30
31. S9 :-Non clinical evaluation for anti cancer drugs
s10:photosafety evaluation(eg: methotrexate)
S11:non clinical paediatric safety
S12:non clinical biodistribution studies for gene
therapy(gentic material introduction to make proteins)
31
32. •Efficacy is the capacity to produce an effect
(eg, lower blood pressure).
Efficacy can be assessed accurately only in ideal
conditions (ie, when patients strictly adhere to
the dosing schedule). Thus, efficacy is
measured under expert supervision .
Each drug behave differently in each individual
deoending upon genetic makeup of an
individual( pharmacogenomics)
32
33. EFFICACY:
El:- Clinical Safety
E2A-E2F:-Pharmacovigilance (mechanism of
handling n reporting ADRs)
E3:- Clinical Study Reports
E4 :- Dose-response Studies
E5:- Ethnic Factors(Genetic,physiological,env)
E6:- Good Clinical Practice
E7:Clinical Trials in generic population
E8:General consideration for clinical trials
E9:-statistical principle for clinical trials
E10:Choice of control group in clinical trials
E11:-Clinical trial in paediatric population
33
34. E14:- Clinical Evaluation of QT interval for non
anti arrhythmic drugs
E15:-Pharmacogenomics
E16:-Qualification of genomic
biomarkers(biological measures – B.p,heart
rate,triglycerides etc)
E17:-Multiregional clinical trials
E18:-Genomic sampling
E19:-Safety data collection
E20:Adaptive clinical trials
34
35. Multidisciplinary Guidelines Those are the
cross-cutting topics which do not fit
uniquely into one of the Quality, Safety and
Efficacy categories. It includes the ICH
medical dictionary for regulatory activities
(MedDRA), the Common Technical
Document (CTD) and the development of
Electronic Standards for the Transfer of
Regulatory Information (ESTRI).
Ctd –set of specification for manufacturer n
is used across European countries divided
into 5 module
35
37. MULTIDISCIPLANARY:
MI : MedDRA Terminology
M2 : Electronic Standards
M3 . Nonclinical Safety Studies
M4 : Common Technical Document
M5:-Data element and standard for drug
substance
M6: Gene Therapy
M7 : Mutagenic impurities
37
39. REFERENCE :
ICH Official web site : ICH
Ames test-a test for Mutagenicity: Principle, Procedure and Application
- Online Biology Notes
Physical pharmacy by cvs Subramanyam.
39