The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
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.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
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.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
It a detailed description of European Union and Medicines and Healthcare Products Regulatory agency with documentation process of filing MAA application.
brief overview on oligonucleotide, oligonucleoside and its application in medicine. given the basic knowledge as well about the DNA and its composition.
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
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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
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
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.
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
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.
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
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
- 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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Regulatory requirement of EU, MHRA and TGA
1. REGULATORY REQUIREMENTS OF
EU, MHRA, TGA AND ROW
COUNTRIES
Presented by: Guided by:
Himal Barakoti Dr. Satyendra Deka
M. Pharm, 1st Sem Associate Professor
Department of Pharmacy Department of Pharmacy
Assam Down Town University Assam Down Town University
2. CONTENTS:
European Union (EU)
European Medicines Agency (EMA)
MHRA
TGA
ROW Countries
References
2
3. EUROPEAN UNION
Intergovernmental political and economic union of 28 European
countries having internal single market through the standardized
systems of laws.
Established under the name in 1992 by the Treaty on European
Union (the Maastricht Treaty)
European Medicines Agency (EMA) is a decentralized agency
of the European union.
EMA protects public and animal health by ensuring that all
medicines available on the EU market are safe, effective and
of high quality.
3
4. The Agency is responsible for the scientific evaluation,
supervision and safety monitoring of the medicines
developed by pharmaceutical companies for the use in EU.
EMA and the Member States cooperate and share expertise in
the assessment of new medicines and of new safety
information.
By working closely together, Member States reduce
duplication, share the workload and ensure the efficient
and effective regulation of medicines across the EU.
4
5. MARKET AUTHORIZATION
To protect public health and ensure the availability of high
quality, safe and effective medicines for European citizens, all
medicines must be authorized before they can be placed on
the market in the EU.
The Agency’s Committee for Medicinal Products for Human
Use (CHMP) or Committee for Medicinal Products for
Veterinary Use (CVMP) carries out a scientific assessment of
the application and gives a recommendation to the European
Commission on whether or not to grant a marketing
authorization.
EMA enables one application, one assessment, one
market authorisation for the whole of the EU.
A European Public Assessment Report, or EPAR, is published
for every human or veterinary medicine that has been granted
or refused a marketing authorization following an assessment
by EMA. 5
6. THE ROLE OF EMA
EMA plays an important role in the regulation of
medicines in the EU. On the basis of scientific assessments
carried out, it grants or refuses, changes or suspends
marketing authorizations for medicines that have been
submitted via the centralized procedure.
The European Commission can also take action
concerning other aspects of medicine regulation:
Right of initiative – it can propose new or amended
legislation for the pharmaceutical sector;
Implementation – it can adopt implementing measures as
well as oversee the correct application of EU law on
pharmaceuticals;
Global outreach – it ensures appropriate collaboration with
relevant international partners and promotes the EU
regulatory system globally. 6
7. GUIDELINES AND SCIENTIFIC ADVICE
EMA prepares scientific guidelines in cooperation with
experts from its scientific committees and working
groups.
These guidelines reflect the latest thinking on developments in
biomedical science.
They are available to guide the development programmes of
all medicine developers who wish to submit an application for
a marketing authorisation in the EU, and to ensure that
medicines are developed consistently and to the highest
quality.
EMA also gives product-specific scientific advice to
companies for the development of medicines.
7
8. AUTHORIZATION AND SUPERVISION OF
MANUFACTURERS
Manufacturers, importers and distributors of medicines in the
EU must be licensed before they can carry out those
activities.
The regulatory authorities of each Member State are
responsible for granting liscences for such activities taking
place within their respective territories.
All manufacturing and importing licenses are entered into
EudraGMDP, the publicly-available European database
operated by EMA.
Manufacturers listed in the application of a medicine to be
marketed in the EU are inspected by an EU competent
authority.
Inspection outcomes can be accessed by all Member States
and are made publicly available across the EU through
EudraGMDP. 8
9. In order to be imported into the EU, an active pharmaceutical
ingredient needs to be accompanied by a Written
Confirmation issued by the competent authority of the
country where it is produced, confirming that the good
manufacturing practice (GMP) applied is at least
equivalent to the recognized EU GMP standards.
Every batch of medicines must be certified as having been
manufactured and tested in accordance with GMP and in
conformance with the marketing authorization before it can be
released onto the market in the EU.
If the product is manufactured outside the EU and has been
imported, it needs to undergo full analytical testing in the EU.
9
10. SAFETY MONITORING OF MEDICINES
The European regulatory system for medicines monitors the
safety of all medicines that are available on the European
market throughout their life span.
All suspected side effects that are reported by patients and
healthcare professionals must be entered into EudraVigilance,
the EU web-based information system operated by EMA that
collects, manages and analyses reports of suspected side
effects of medicines.
These data are continuously monitored by EMA and the
Member States in order to identify any new safety information.
The committee provides advice and recommendations to
the European medicines regulatory network on risk
management planning and benefit-risk assessment for
medicines after marketing.
10
11. CLINICAL TRIALS
The authorisation and oversight of a clinical trial is the
responsibility of the Member State in which the trial is taking
place.
The European Clinical Trials Database (EudraCT) tracks
which clinical trials have been authorised in the EU. It is
used by NCAs and clinical-trial sponsors to enter
information protocols and results of clinical trials.
A subset of this information is made publicly available by EMA
via the EU clinical trials register.
11
12. MHRA
Medicines and Healthcare products Regulatory Agency is
an executive agency of the Department of Health of United
Kingdom.
MHRA was set up in April, 2003 bringing together the function
of medicines Control Agency (MCA) and the Medical
Devices Agency (MDA).
MHRA is responsible for ensuring that medicines and medical
devices work, and are acceptably safe.
MHRA functions when the company wants to start clinical
trials in patients.
12
13. ROLES
Licensing
Manufacturer and dealer licenses
Clinical trial licences
Parallel import licenses
o Safety and efficacy monitoring
o Enforcements of laws
o Regulation of clinical trials
o Providing information to public and health professionals
o MHRA does not regulate dietary supplements, veterinary
products and cosmetics.
13
14. LICENSING PROCESS
Application of Clinical Trials
Evaluation by MHRA
Satisfies Doesn’t satisfies
Clinical trials
Clinical trials results
Assessment of data
by experts
Doesn’t satisfy Satisfies
No license
Gives
Marketing
Authorization
14
15. MARKETING AUTHORIZATION
Majorly by 4 processes:
1. Centralized procedures
In EU, a company may submit a single application to the
EMA for a marketing authorization that is valid
simultaneously in all EU Member States.
2. National procedures
Each EU member states has its own procedures for the
authorization of medicines that fall outside the scope of the
centralized procedure.
Applicants must submit an application to the competent
authority of the Member State.
15
16. 3. Decentralized Procedure
Using the decentralized procedure, companies may apply
for simultaneous authorization on more than one EU country
of products that have not yet been authorized in any EU
country and do not fall within the mandatory scope of the
centralized procedure.
4. Mutual recognition procedure
Here, a medicine is first authorized in one EU member state,
in accordance with the national procedures of that country.
Following this, further marketing authorizations can be
sought from other EU countries in a procedure whereby
the countries concerned agree to recognize the validity
of the original, national marketing authorization.
16
17. RENEWAL OF LICENSE
New Marketing Authorization (MA) are valid for 5 years and
then may be renewed on the basic of a re-evaluation of the
risk-benefit balance.
Applications for renewal should be submitted at least six
months before expiry.
New MAs
(for 5 years)
Re-evaluations
MAs for
lifetime
MAs for 5
years 17
18. TGA
Therapeutics Goods Administration is the regulatory body for
therapeutic goods in Australia.
TGA is responsible for conducting assessment and monitoring
activities to ensure that therapeutic goods available in
Australia are of an acceptable standard.
The objectives of Therapeutic Goods Act 1989, which came
into effect on 15 Feb, 1991 is to provide a national
framework for the regulation of therapeutic goods in
Australia to ensure quality, safety and efficacy of the
medicines and ensure quality, safety and performance of
medical devices.
18
19. Essentially therapeutic goods must be entered on the
Australian Register of Therapeutics goods (ARTG) before
they can be supplied in Australia.
ARTG is a computer database of information about
therapeutic goods for human use approved for supply in, or
export from, Australia.
Australian manufacturers of all medicines must be licensed
under part 4 of the Therapeutic Goods Act1989 and their
manufacturing process must comply with the principles of
GMP.
Once approved for marketing in Australia, medicines are
included in the ARTG and can be identified by the AUST R
number (for registered medicines) or an AUST L number
(listed medicines) that appears on the packaging of the
medicines.
19
20. Medicines that are assessed to be higher risk are individually
evaluated for quality, safety and efficacy. Higher risk products
approved by the TGA are included on the ARTG as
registered medicines.
Listed medicines are low risk medicines and are included on
the ARTG via low-cost and streamlined electronic application
and validation process.
20
21. REGULATORY FRAMEWORK
In consultation with industries, TGA has developed Australian
Regulatory Guidelines For The Complementary Medicine
(ARGCM) to assist sponsors of complementary medicines to
meet their legislative obligations.
Products are evaluated by the TGA for quality, safety and
efficacy under the provision of section 25 of the Therapeutic
Goods Act 1989.
Products in category include:
Products included in Schedule of Pharmaceutical Benefits
Products containing sunscreen active ingredient that is not
included in the list of sunscreening agent permitted as active
ingredient in listed products
Products that make therapeutic claims other than sun screening.
21
22. Elements to Regulate
Licensing and Audit of Manufactures
Act requires each Australian manufacturer of medicinal
products for human use to hold a manufacturing license.
License holders are required to comply with the
manufacturing principles of the Act, including compliance
with GMP.
Pre-Market Assessment
This includes study of toxicity and dosage form of
medicines. The product risk is determine by side effects,
inappropriate self medication, adverse effect for prolonged
use.
22
23. Post-Market Regulatory Authority
The essential elements of this systematic rick-based
approach include:
1. Monitoring of adverse reactions to medicines.
2. Targeted and random surveillance in the market place.
3. An effective, responsive and timely recalls procedure.
4. Audit of GMP.
5. Effective controls for the advertising of therapeutic
goods.
23
25. REGULATORY REQUIREMENTS IN ROW
COUNTRIES
Key function of RA:
1. Product registration
2. Regulation of drug manufacturing, importation and
distribution
3. Adverse drug reaction monitoring
4. Licensing of premises, person and practices.
5. Main goal of the agency is to guarantee the safety, efficacy
and quality of the available drug product.
25
26. INDIA: REGULATORY
BODIES
Central Drug Standard Control Organization (CDSCO)
Ministry of Health and Family Welfare (MHFW)
Indian council of Medical Research (ICMR)
Indian Pharmaceutical Association (IPA)
Drug Technical Advisory Board (DTAB)
Central Drug Testing Laboratory (CDTL)
Indian Pharmacopoeia Commission (IPC)
National Pharmaceutical Pricing Authority (NPPA)
26