The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device life as the industry knows it. Everything from routine inspections to premarket notification reviews have been disrupted by the pandemic, and clinical trials are no exception. The obstacles the COVID-19 pandemic poses to clinical trials include quarantines, site closures, travel limitations, supply chain interruptions, and overall safety concerns about site personnel and trial subjects...
The Regional Expert Committee on Traditional Medicine for COVID-19 formed by the World Health Organization (WHO), the Africa Centre for Disease Control and Prevention and the African Union Commission for Social Affairs has endorsed a protocol for phase III clinical trials of herbal medicine for COVID-19 as well as a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.
The Regional Expert Committee on Traditional Medicine for COVID-19 formed by the World Health Organization (WHO), the Africa Centre for Disease Control and Prevention and the African Union Commission for Social Affairs has endorsed a protocol for phase III clinical trials of herbal medicine for COVID-19 as well as a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
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
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
The value of real-world evidence for clinicians and clinical researchers in t...Arete-Zoe, LLC
In the midst of a rapidly spreading global pandemic, real-world evidence can offer invaluable insight into the most promising treatments, risk factors, and not only predict but suggest how to improve outcomes. Despite overwhelming news coverage, significant knowledge gaps regarding COVID-19 persist. The current uncertainties regarding incidence and the case fatality rate can only be addressed by widespread testing. But the paucity of testing, and diversity of approaches implemented in different countries, particularly among the general asymptomatic public, perpetuates a lack of understanding about spread and infectivity. The essential indicators that would describe the pandemic more accurately can be obtained using real-world data (RWD). To that purpose, we designed a data collection tool to collect data from hospitals that treat COVID-19 patients. The captured data will enhance our understanding of the COVID-19 pandemic, identify risk factors relevant for triage, relate to other similar seasonal infections and gain insight into the safety and efficacy of experimental and off-label therapies. Knowledge derived from a focused data collection effort will enable clinicians to adjust rapidly clinical protocols and discontinue interventions that turn out to be ineffective or harmful. By deploying our elegantly designed survey to capture routine clinical indicators, we avoid placing an additional burden on practitioners. Systematically generating real-world evidence can decrease the time to insight compared to randomized clinical trials, improving the odds for patients in rapidly changing conditions.
This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Assignment on Covid 19 | Tutors India.pptxTutors India
Tutors india thesis and dissertation writing help guarantees that your dissertation is confidential, and so you do not have to worry about it.
For #Enquiry:
World: https://www.tutorsindia.com
UK: https://www.tutorsindia.com/uk
UAE: https://tutorsindia.com/ae/
Australia:https://www.tutorsindia.com/au/
Newzealand: https://www.tutorsindia.com/nz/
(UK): +44-1143520021
Mail: info@tutorsindia.com
Mail: info@tutorsuk.co.uk
(Whatsapp): +91-8754446690
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
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
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
The value of real-world evidence for clinicians and clinical researchers in t...Arete-Zoe, LLC
In the midst of a rapidly spreading global pandemic, real-world evidence can offer invaluable insight into the most promising treatments, risk factors, and not only predict but suggest how to improve outcomes. Despite overwhelming news coverage, significant knowledge gaps regarding COVID-19 persist. The current uncertainties regarding incidence and the case fatality rate can only be addressed by widespread testing. But the paucity of testing, and diversity of approaches implemented in different countries, particularly among the general asymptomatic public, perpetuates a lack of understanding about spread and infectivity. The essential indicators that would describe the pandemic more accurately can be obtained using real-world data (RWD). To that purpose, we designed a data collection tool to collect data from hospitals that treat COVID-19 patients. The captured data will enhance our understanding of the COVID-19 pandemic, identify risk factors relevant for triage, relate to other similar seasonal infections and gain insight into the safety and efficacy of experimental and off-label therapies. Knowledge derived from a focused data collection effort will enable clinicians to adjust rapidly clinical protocols and discontinue interventions that turn out to be ineffective or harmful. By deploying our elegantly designed survey to capture routine clinical indicators, we avoid placing an additional burden on practitioners. Systematically generating real-world evidence can decrease the time to insight compared to randomized clinical trials, improving the odds for patients in rapidly changing conditions.
This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Assignment on Covid 19 | Tutors India.pptxTutors India
Tutors india thesis and dissertation writing help guarantees that your dissertation is confidential, and so you do not have to worry about it.
For #Enquiry:
World: https://www.tutorsindia.com
UK: https://www.tutorsindia.com/uk
UAE: https://tutorsindia.com/ae/
Australia:https://www.tutorsindia.com/au/
Newzealand: https://www.tutorsindia.com/nz/
(UK): +44-1143520021
Mail: info@tutorsindia.com
Mail: info@tutorsuk.co.uk
(Whatsapp): +91-8754446690
Conduct of clinical Trials during covid 19 a CTTI webinar Pamela Tenaerts
This week, stakeholders from across the clinicaltrials ecosystem submitted experiences and insights related to the FDA’s new guidance on the #conduct of clinical trials of medical products during the current hashtag#COVID-19 pandemic. We shared best practices and experiences in a webinar and our slides are now available in advance of posting the webinar.
On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of COVID-19 treatments. With over 920,000 confirmed cases globally, the Coronavirus pandemic is forcing the FDA to create a rapid pathway for treatments. The new Coronavirus Treatment Acceleration Program (CTAP) is the FDA’s answer to the massive surge of inquiries across the public, academic, and private sectors looking for ways to treat COVID-19...
Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
Chapter 19
Clinical Trials
Clinical Trials
“The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”
— Sidney M. Wolfe
Lecture Overview
Research and Development Investments Fund a Complex Multistage Pathway
Clinical Trials of Generic Drugs
Health Risk Assessments
Expanded Access Protocols
Termination of Clinical Trials
Observational Studies
International Clinical Trials
Informed Consent in General
Transparency and Full Disclosure in Clinical Testing
Financial Conflicts of Interest
Commitment to the Life Sciences
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Clinical trials. In Health care management and the law: Principles and applications (pp. 389-412). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Research and Development Investments Fund a Complex Multistage Pathway
Some major expenses are research materials, advanced computers, and other highly sophisticated machines that support research activities, and salaries of scientists. Stage specific activities include:
Drug discovery
Preclinical testing
Clinical trials
Approval by the FDA
Post marketing surveillance
Research and Development Investments Fund a Complex Multistage Pathway
Drug Discovery:
While most compounds will never be approved for use, each one is evaluated to determine its potential value compared to existing therapies, complexity of large scale manufacturing, and other factors.
Preclinical Testing:
Candidate drugs from the discovery stage receive 1 to 3 years of extensive testing to assess safety and show biological activity against a disease.
Chemical tests establish the purity, stability, and shelf life of a compound.
Manufacturing tests determine mass production of the drug.
Pharmaceutical development studies explore dosing, packaging, and formulation of the drug.
Research and Development Investments
Fund a Complex Multistage Pathway: Clinical Trials
For drugs in development, there are low odds of reaching the market.
While Phase I, II, and III of studies are taking place, research investigators are also conducting toxicity tests and other long-term safety evaluations, evaluating dosage forms, planning for mass production, designing packaging, and preparing the extensive application required for FDA approval.
One out of five drugs that enter clinical testing is never approved by the FDA:
20% of the drugs that enter Phase I are approved to enter Phase II
30% of the drugs that enter Phase II are approved to enter Phase III
60% of the drugs that enter Phase III are approved for a new drug application
80% of the new drug applications are approved by the FDA for market entry
Research and Development Investments Fund a Complex Multistage Pathway
Approval by the U.S. Food and Drug Administration
According to the FDA, the documentation required in a new drug application is supposed to tell the whole story of a ...
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, was officially declared a pandemic back in early March. Since then the medical device industry has been trying to adjust to the far-reaching obstacles presented by this public health emergency, such as global supply chain shortages, social distancing risks, and more. As such, the FDA has also had to make significant and unprecedented changes to mitigate risks and make sure that public safety is continuously protected. In this paper, we will explore the FDA’s response to COVID-19 cohesively, looking at how the agency has had to modify some of its processes and policies, relax regulatory requirements, and what the future of the regulatory-landscape looks like for the medical device industry post-COVID-19...
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...ClinosolIndia
Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research:
Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE).
Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design.
Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events.
Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions.
Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period.
Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.
INTRODUCTION
IND TYPES
IND CATEGORIES
THE IND APPLICATION MUST CONTAIN INFORMATION IN THREE BROAD AREA
THE REGULATORY ENVIRONMENT AND FDA ROLE
LIST OF IMPORTANT SECTIONS
GENERAL PRINCIPLES
INVESTIGATIONAL NEW DRUG GUIDANCE AND PLANNING
FDA FORM 1571
FDA FORM 1572
FDA FORM 3674
SUBMITTING AN IND
FOLLOWING RECEIPT OF IND BY THE FDA
RESPONDING TO A CLINICAL HOLD
REGULATORY REQUIREMENTS FOR AN IND DURING STUDY AND AT COMPLETION
PROTOCOL AMENDMENTS (21 CFR 312.30)
INFORMATION AMENDMENTS (21 CFR 312.31)
SAFETY REPORTS (21 CFR 312.32)
ANNUAL REPORTS (21 CFR 312.33)
WITHDRAWAL, TERMINATION, AND INACTIVATION
MONITORING RESPONSIBILITIES FOR SPONSOR-INVESTIGATORS
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Many attempts have been made to produce a long-term, cost-effective, and biocompatible scaffold; however, most attempts fail to achieve this. An example would be collagen-based scaffolds. Collagen is the body’s most abundant protein and is thus highly biocompatible. Unfortunately, collagen-based scaffolds have disappointing long-term properties including poor shape retention and mechanical strength. Many types of these bio-scaffolds exist including protein-based, carbohydrate-based, polymer-based, or a combination of these...
Stability Testing of Pharmaceuticals and SupplementsEMMAIntl
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability testing is required depending on the location of registration and agencies involved in its approval. Stability testing is the method of testing a product's safety, efficacy, and chemical composition after a set period...
Millions in the United States alone have an allergic condition, with many of these allergies being related to food. According to the Food Allergy Research & Education organization (FARE) 32 million Americans have food allergies. Of those 32 million, 200,000 require emergency medical care for allergic reactions from those foods. A common misconception is that food intolerance is a food allergy when in actuality that is its own unique category...
The field of biomedical engineering is a new, widely researched, and well-funded industry that aims to tackle problems in medicine and health by providing engineered solutions. These solutions might be delivered in the form of electrical hardware, chemicals, or even software. Given the extensive range of applications that exist in the medical device industry, the field is continuously accelerating its innovations in technology via an abundance of research and innovation outlets in countless interrelated fields. One of the many fields that are fundamentally fueling the growth of the biomedical industry is material science...
Investigating Ketamine for Parkinson’s DiseaseEMMAIntl
In May 2021, the FDA approved an Investigational New Drug (IND) application from PharmaTher Holdings Ltd., to proceed with a Phase Two clinical trial. PharmaTher Holdings Ltd. is a psychedelics biotech organization that focuses on research and development, and commercialization of psychedelics to treat pain and neurological disorders, and mental illnesses. This company is headquartered in Vancouver, Canada...
Aduhelm, an Accelerated Approval for Alzheimer’sEMMAIntl
Alzheimer’s disease is the most common cause of dementia, especially in patients aged 65 and older1. Alzheimer’s disease is a neurodegenerative disease that has a direct correlation to age: as age increases, the likelihood of developing Alzheimer’s increases as well. Alzheimer’s has long been a subject of discussion in the pharmaceutical industries and, until the FDA’s recent accelerated approval of Aduhelm earlier this month, the most recent treatment approved for Alzheimer’s was in 2003, almost two decades ago. The FDA’s approval of Aduhelm represents the first-of-its-kind treatment and is the first therapy that aims to interrupt the underlying physiological pathway of Alzheimer’s, rather than simply attempt to treat its symptoms...
Every June 14th, the World Health Organization (WHO) hosts World Blood Donor Day to raise awareness all over the globe for how crucial the need for safe blood is in the healthcare industry. In the US and Canada alone, 43,000 pints of blood are used each day for life-saving procedures and treatments...
Starting in Summer 2021, a new type of COVID vaccine could be available. Known as a protein subunit vaccine, this vaccine contains a spike protein that the other three vaccines are missing. The other vaccines, Pfizer, Moderna, and Johnson & Johnson, contain instructions for the spike protein but do not actually include the spike protein in the vaccination. The three vaccines allow our cell bodies to make the protein up for itself...
June 14th through the 20th is Men’s Health Week, which is a great opportunity to heighten awareness for men’s depression. There is a theme in society applicable to most men as they tend to internalize depressive thoughts, not allowing for a proper diagnosis. There are four major reasons men do not reach out for help with their depression: failure to recognize the depression consuming them, downplaying signs and symptoms, reluctance to converse about their feelings with others, and resisting mental health treatment...
Celebrating Pride Month at EMMA InternationalEMMAIntl
June 1 started the celebration of Pride Month, which commemorates Lesbian, Gay, Bisexual, and Transgender members. Celebrating Pride Month is also more than celebrating members of the LGBTQIA+, this month is also about recognizing that diversity fuels innovation and collaboration among a variety of industries, including the life sciences...
Growth and Integration of ML/AI in BiotechEMMAIntl
The biotechnology and pharmaceutical industries are heavily reliant on collecting, storing, and analyzing data for both R&D as well as production purposes. The large, countless, and rapidly growing sets of data are critical for researchers and scientists to accelerate progress in the medical industry. As our technologies advance and our capacity to store data continue to increase, we must continue to find new ways to efficiently analyze data. Researchers at the European Bioinformatics Institute (EMBL-EBI) have determined that nucleotide and proteomics data is growing at an exponential rate, with the amount of data stored on their servers doubling each year...
Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was initially developed in Japan in the 1960s but was popularized in the US by the automotive industry in the 1980s . QFD is a tool often leveraged by Total Quality Management (TQM), which is a quality principle that customers define quality and subsequently should be prioritized at all stages of the product, both pre-and post-production...
New digital health technology is coming out every day and is changing the course of the MedTech industry as we know it. Many physicians are making the transition to using these digital health devices and technologies to improve patient care and outcomes. Some of this increase can be attributed to COVID-19 of course as it enabled them to provide care for patients remotely. However, many of these digital health devices and technologies have been around for a bit, so what caused the hesitation in adapting them sooner and what are some of the great perks of this new wave of medical care?
Immune Systems After the COVID-19 PandemicEMMAIntl
Everyone has heard that immune systems weaken when they are sheltered, but is that really the case? As we are now over one year into lockdowns and social distancing, many are becoming concerned that after the pandemic immune systems are going to falter after being isolated for such a long period, and many adults are concerned to resume a “normal” life due to this...
Stability Testing Requirements for PharmaceuticalsEMMAIntl
Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence data on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors. It also establishes a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions...
EMMA International is continuing to celebrate Women’s Health Week! While there are so many reasons Women’s Health Week is important, one of the best things to come out of this week is the attention it brings and the reminders that we should all consider our health and take steps to ensure a healthy future...
Happy National Women’s Health Week! In honor of this week bringing light to important women’s health issues, I wanted to walk through a brief history of innovations that shaped one of the largest facets of women’s health – reproductive health...
In the work from home era, we all realized how important it is to digitize our important documents and what a lifesaver digital signatures are. With everything now getting electronically stored, electronic signatures and documentation are slowly replacing the paper-based system. That means we must now get ready to expand our digital storage plans rather than buying new filing cabinets...
Considerations for Biocompatibility EvaluationEMMAIntl
Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their product development process. ISO 10993-5 and ISO 10993-10 are FDA-recognized standards for biocompatibility. Whether you perform these studies in-house or send out samples to a third-party lab the protocol for biocompatibility assessment must be conducted in accordance with ISO 10993...
Restoring the Earth for a Healthier FutureEMMAIntl
Today marks the 52nd anniversary of the birth of the true modern environmental movement, however, you probably know it as Earth Day. Early in the pandemic, many hoped that the lockdowns would help the Earth heal as people began to stay home, stopped commuting, and some factories even had paused production. Unfortunately, as things are beginning to open back up emissions are on the rise again and we need to continue to think about the future consequences...
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
1. Clinical Trials During COVID-19
By: Madison Wheeler
The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device
life as the industry knows it. Everything from routine inspections to premarket notification reviews have
been disrupted by the pandemic, and clinical trials are no exception. The obstacles the COVID-19
pandemic poses to clinical trials include quarantines, site closures, travel limitations, supply chain
interruptions, and overall safety concerns about site personnel and trial subjects. Despite the pandemic,
however, the agency recognizes that clinical trials may need to begin or continue throughout the public
health emergency. The FDA has put guidance in place which should assist trial sponsors to assure the
safety of participants, maintain compliance with good clinical practices (GCP), and overall minimize any
risks to trial integrity.
Ensuring the safety of clinical trial participants continues to be the top priority for the agency, so they
have outlined key factors that should be considered when deciding to suspend, continue, or initiate a new
study during the pandemic. Trial sponsors should weigh out if it is necessary to amend or deviate from
study processes and/or procedures to keep participants safe. For example, if it is feasible to conduct visits
via teleconference versus physically going to the investigational site that would be an acceptable
deviation to continue the trial. Typically, any amendments or deviations would need formal approval by
the IRB and notification to the FDA before being implemented; however, due to the pandemic, the agency
has relaxed that regulation. The guidance allows for submitting one consolidated summary of
implemented changes that occurred before approval if it is submitted as soon as possible and documented
in all relevant reports.1
When considering whether to halt the clinical trial or not, sponsors should examine if participants are
benefitting from the investigational products and if there could be any adverse effects from stopping the
treatment. Part of this consideration should be the seriousness of the disease being treated,whether there
are any alternative treatments,and what the risks are of switching treatments.2
All considerations and any
contingency measures taken to ensure participant safety need to be fully documented in all trial reports.
Overall, there are a lot of unknowns when it comes to navigating clinical trials during the COVID-19
pandemic. With now over 1 million positive cases in the United States, it is critical to ensure that all
measures are taken to prioritize participant safety.3
If you are considering how to begin or continue a
1 FDA (April 2020) Guidanceon Conduct of Clinical Trials of Medical Products duringCOVID-19 PublicHealth
Emergency retrieved on 04/29/2020 from: https://www.fda.gov/media/136238/download
2 Mehzer, RAPS (April 2020) Clinical trialsduringCOVID-19:Updates from FDA, MHRA, and TGA retrieved on
04/29/2020 from: https://www.raps.org/news-and-articles/news-articles/2020/4/clinical-trials-during-covid-19-
updates-from-fda-m
3 CDC (April 2020) Coronavirus Disease2019 Cases in the US retrieved on 04/29/2020 from:
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html
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clinical trial during the pandemic, EMMA International can help you prepare. Reach out to us at
info@emmainternational.com or give us a call at 248-987-4497 to see how we can help!