Lanzule is a pharmaceutical company involved in drug safety, including pharmacovigilance, drug discovery, and drug development. It reports to regulatory authorities in Nigeria, Ghana, the EU, and the US. The document discusses the process of evaluating drug safety from pre-clinical trials through post-marketing surveillance. It outlines the changing requirements for documenting pharmacovigilance systems in Europe, including phasing out DDPS in favor of the PSMF. The key aspects of drug safety are assessing safety during development, monitoring adverse events after approval through pharmacovigilance, and reporting any serious safety issues to regulatory authorities.
Firstly it was a division of Chemistry, then named as The Bureau Of Chemistry.
In Jully1930,the name was shortened to Food And Drug Administration.
Up to 1940,FDA was under Department Of Agriculture.
In 1968,it become part of Public Health Service within Health Education And Welfare (HEW).
Firstly it was a division of Chemistry, then named as The Bureau Of Chemistry.
In Jully1930,the name was shortened to Food And Drug Administration.
Up to 1940,FDA was under Department Of Agriculture.
In 1968,it become part of Public Health Service within Health Education And Welfare (HEW).
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist.
seminar presentation
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)Naman Ruhela
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist.
seminar presentation
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)Naman Ruhela
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
Está mais que na Hora de levarmos a sério esta Extraordinária filosofia de gestão que é o Revenue management, acho que acabou o espaço dos curiosos de plantão. Revenue Management não é privilégio da hotelaria, mas pode e deve ser usado por toda a empresa que deseje o SUCESSO
Por medio del cual se expide y modifica el estatuto tributario y de rentas del municipio de Subachoque, se adiciona la normatividad tributaria sustantiva, el procedimiento tributario y el régimen sancionatorio para el municipio.
Post Marketing Surveillance and Pharmacoepidemiologyijtsrd
Post Marketing Surveillance PMS and pharmacoepidemiology are essential components of drug safety monitoring and effectiveness evaluation in real world clinical settings. PMS involves the continuous monitoring of pharmaceutical products after regulatory approval to detect and assess adverse events and safety issues that may not have surfaced during pre marketing clinical trials. Pharmacoepidemiology, on the other hand, employs epidemiological methods to study the effects of drugs in large populations, utilizing real world data from various sources. This article explores the significance of PMS and pharmacoepidemiology in ensuring patient safety, highlights their mutual contributions in research, and underscores the importance of collaborative efforts between regulatory agencies, academia, and pharmaceutical companies. The challenges related to data quality, privacy, and ethical considerations are discussed, along with potential advancements in methodologies and the integration of new technologies for future research and vigilance in drug safety and public health. Dr. Farheen Yousuf "Post-Marketing Surveillance and Pharmacoepidemiology" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59690.pdf Paper Url:https://www.ijtsrd.com/pharmacy/other/59690/postmarketing-surveillance-and-pharmacoepidemiology/dr-farheen-yousuf
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma group, Monthly magazine Volume 7 has been released with
3 News Uptoday
30 New Guidance and New MAPP Release
37 Audit Findings
483 Observations
- 483 of Alexander Infusion
Warning Letters
- John W Hollis Inc.
EMA Non-Compliance Reports
- Hebei Dongfeng Pharmaceutical Co., Ltd, China
- I.C.I. International Chemical Industry, Italy
41 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Adverse Drug Reaction (ADR) reporting is a vital process in pharmacovigilance that involves the identification, documentation, and analysis of adverse effects or unexpected reactions to medications. Healthcare professionals, including clinical pharmacists, play a crucial role in reporting ADRs to regulatory authorities. Timely and accurate reporting helps enhance patient safety, contributes to the continuous monitoring of drug safety profiles, and facilitates informed decision-making in healthcare. ADR reporting is a proactive measure to ensure the ongoing assessment and improvement of medication safety for the benefit of patients and the broader healthcare system.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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.
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
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
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.
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
CDSCO and Phamacovigilance {Regulatory body in India}
Dossier on drug safety
1. DOSSIER ON DRUG SAFETY
About the Company
QUADRI SULEIMAN LANZULE INC 4/3/2016
Lanzule is a pharmaceutical servicing company. We are involved in
Pharmacovigilance, Drug discovery and Drug Development. Lanzule was
incorporated 21st
of October, 2015. Our offices are located in Abuja, Nigeria and London,
UK, we would report to Regulatory Authorities in Nigeria, Ghana, EU, and the USA.
Services
General Pharmacovigilance, medical device vigilance.
The Detailed Description of the Pharmacovigilance System (DDPS) is being
replaced by the requirement for a Pharmacovigilance System Master File (PSMF).
The Old System (DDPS): The old style document was defined within Volume 9a of
the Rules Governing Medicinal Products in the EU (drug safety regulations) which
detailed responsibilities for Marketing Authorizations applicants and holders, plus
the Competent Authorities in each member state who would deal with them.
Volume 9A was specific on the elements of drug safety that should be included in
the DDPS, but in general left it to the Applicant to provide the detail.
Although the DDPS will be phased out completely for all authorisations in 2015,
while the DDPS is still being used, its method of working is now driven by Good
Vigilance Practice (GVP). The EU is currently in an interim state and hence DDPS is
still being used.
The New System: Pharmacovigilance System Master File (PSMF) - Since 2012 the
new regulations, from which GVP is derived affects:
1. All new applications for Marketing Authorisation within the EU.
2. All existing Marketing Authorisations.
Instead, new applications and applications for variation must include summaries of
the drug safety systems, details of the appointment of the EU QPPV – and details
of where the PSMF is located for inspection. All pharmaceutical companies
marketing products in the EU are affected as all Marketing Authorisations will
eventually need to be migrated over to the new system by July 2015 or risk having
2. DOSSIER ON DRUG SAFETY
Lanzule Inc Page 1
DOSSIER ON
DRUG SAFETY
About the Company
Drug Discovery, Drug Development and
Pharmacovigilance.
All new drugs must be evaluated for any
toxicity during their development; so
safety profiles could be established. Once
the basic safety data has been
established, limited doses will be given to
volunteers in clinical trials. Should the
safety profile be acceptable, and
approved by a regulatory body, the drug
would be sold for use in the general
patient population.
Safety assessment of a drug (medicine)
does not stop with issue of a Marketing
Authorisation Approval (MAA).
Pharmacovigilance activities do reveal
insights into hazards associated with
medicinal products, reporting adverse
drug reactions i.e. Drug Drug Interactions
(DDI). Pharmaceutical toxicologists
evaluate toxicity of drugs in the
development programme.
Drug Safety.
Drugs provide significant benefits to
human health. A good number of drugs
are known to cure, stabilise and prevent
diseases. Just as these drugs have helped
improve living conditions of people, they
have undergone rigorous screening and
checks before they are marketed for safe
human consumption. Drug safety involves
assessment, understanding and
prevention of adverse effects of an
investigational Medicinal Product (IMP).
IMP can be active pharmaceutical
substance in the form of drugs, medical
devices and vaccines as defined by
Medicine and Health Products Regulatory
Agency (MHRA) under European Union
Directive 2001/20/EC(1). Marketing
approval of drugs are allowed only if the
benefits outweigh their risks, and in the
U.K the main governmental body
responsible for drug Approval is the
(MHRA) and its U.S.A equivalent is the
Food Drug Administration (FDA)7). The
earliest stages of drug development
begins with preclinical studies where;
extensive research is done in vitro and ex
vivo (cell tissues), before moving onto in
vivo animal studies. The animal studies
should be done in GLP labs, 3R’s and
Animal Scientific Protection Acts 1986.
Preclinical studies most important goal is
to determine safety profiles in short term
and long term treatment effect of IMP (7).
Other data collated from preclinical
studies are the efficacy, pharmacokinetics,
pharmacodynamics and toxicity of such
IMP’s (5).
3. DOSSIER ON DRUG SAFETY
Lanzule Inc Page 2
Approved Clinical Trial Authorisation
must be received in writing from the
MHRA and Research Ethics Committee
(REC) before human clinical trials can
proceed (4). Collated data gives
researchers a prediction of safe starting
doses in clinical trials. Clinical trials are
also known as test in Man and usually
consist of four stages.i.e. Phase I – IV. The
starting dose can be determined using the
NOAEL from preclinical studies and
uncertainty factor based on surface area
ratios. Phase I – III trials are pre-marketing
studies and can take up to 10 years or
more whilst the Phase IV is usually a post
marketing research (2).
Phase I trials are single doses of an IMP
given in increasing amounts usually done
in healthy subjects numbering about 20 -
100 and endpoints are to determine
safety, tolerability, pharmacokinetic
effects and pharmacodynamic effects.
Phase II trials are done in patients of
targeted diseases numbering about 100 -
1000 and endpoints are determined if it is
really safe, pharmacokinetic and
pharmacodynamic effects giving an
indication of how to design the phase III
stage.
Phase III trials are done in patients of
targeted diseases numbering about 1000
– 10000 and its used to build on the data
gained from the first two phases of trials
and at this stage results are extrapolated
to the general Public. At the end of this
stage, Marketing Authorisation
Application of new drug application are
applied for approval from MHRA or FDA
as the case may be, it becomes a Phase IV
trial candidate.
Phase IV trials are post marketing studies
in patients of targeted diseases
numbering from tens of thousands
upwards. At this stage the IMP is
compared to any drugs with similar effects
or properties to determine which is better.
See Appendix 1 for flow chart in the development
of a drug.
A safety and efficacy Update report of all
information about the study drug (IMP) should
be recorded at intervals, which can be supplied to
all investigators and ethic committees (5).
Pharmacovigilance takes off after the post
marketing stage which watches out for any
Adverse Reactions (ADR) of the new medicine.
Pharmacovigilance plays major roles in the deeper
understanding of benefits and risks of medicines
thereby ensuring drug safety throughout the
lifecycle of a new medicine. (8). Adverse events
(AE’s) when reported by study teams during post
marketing trials can be serious adverse events
(SAE). All SAE’s should be reviewed and
investigators should report to the sponsor or
Manufacturing Authorisation Holder.i.e.
pharmaceutical company/manufacturer. All cases
of Suspected Unexpected Serious Adverse
Reactions (SUSAR) of IMP’s new medicines must
be reported to MHRA (9) in the UK or the FDA in
the U.S, the REC (10), the Sponsors and its QA
departments. All fatal life threatening SUSARs
must be reported within 7 calendar days (6) to the
MHRA whilst other SUSARs should be reported to
MHRA within 15 calendar days.
See Appendix 2 for workflow of
Pharmacovigilance.
All documents should be kept safe and archived
for future references and Qualified Person should
4. DOSSIER ON DRUG SAFETY
Lanzule Inc Page 3
ensure that the SOP (3) is followed; the IMP meets
the EU GMP requirements or equivalents. The
process of drug safety involves a large amount of
information that cannot easily be gathered, it
requires a lot of expertise and experience that can
be archived through continuous exposures to
research and clinical trials.
Safety Practices
Data Entry onto company database.
Data review on company database.
Review of safety information from clinical
trials and post marketed products.
Electronic reporting of safety cases to
regulatory Agencies.
Paper reporting of ADRs to Regulatory
Authorities.
Compliance matrices for client and
company review.
Literature searching for ADRs.
Writing safety summaries for literature
articles.
Writing sections of Periodic Safety
Update Reports.
Assessing adverse reactions for potential
signals.
Coding adverse events.
Producing summary safety tables for
client review.
Preparation and training for regulatory
inspections.
Follow up of safety cases to closure.
MedDRA coding.
Adverse event case files production and
archiving.
Understanding and helping with
determining ADR reportability.
SOP review and writing.
Accompanying audits to clients and SOP
review.
Attendance at meetings concerning
possible client work.
On site client work involving any of the
above.
Answering medical enquiries.
Filing of cases and source
documentation.
And many more………
Causes of Adverse Events
Primary Pharmacology.
Secondary Pharmacology.
Physicochemical nature of compound.
Projects Handled
Appendix 1: Brief overview of
Pharmacovigilance Work flow.
Case processing
Case in
Data Entry
Data Review
Medical Review
Quality Review