In MakroCare whitepaper, we have compiled and simplified some of these new policies, revisions, regulatory amendments from registration, labeling, safety reporting, renewal, publishing /eCTD submission of last year and forthcoming years.
The ACSS Consortium And The Generic Medicines Work-Sharing TrialTGA Australia
TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
Text for news feed: TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
The ACSS Consortium And The Generic Medicines Work-Sharing TrialTGA Australia
TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
Text for news feed: TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies to be distributed in Canada. Below are some of the policies that Health Canada rolled out to prevent shortages of supplies and ensuring that safe and effective products are distributed in the market for use...
Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.
The presentation covers the following topics:
- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers
- How these systems have evolved to date to include patients’ experiences
- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:
- How and at what stage should patients be involved in HTA processes?
- What are the criteria for successful involvement of patients in HTA processes?
- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?
- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?
Impact of the Government Shutdown on Synchrogenix FDA-regulated ClientsDarshan Kulkarni
As of Dec 22nd, some 800,000 federal workers either furloughed or working without pay. Will this compromise the FDA's mission to protect public health?
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 3 has been released with
News Uptoday
New Guidelines
Audit Findings
Guest of the Month
Regulation of the Month
New Developments of Excipient Regulations in ChinaMilliporeSigma
Watch the webinar recording: https://bit.ly/2SE4DkZ
Abstract:
If you want to market your drug in China, are you aware that the excipients used in your drug need to be registered and to be compliant with the Chinese Pharmacopoeia?
Since 2017, Chinese Health Authority has published new regulations for Co-Review procedure of API, excipient and packaging material. NMPA and CDE are developing the pharmaceuticals regulations continuously. Focusing on the unique regulatory requirements for the registration of excipients, we will give you an update on the recent changes in excipient regulations, the published ChP 2020 and the regulatory trends for excipients in China.
In this webinar, you will learn:
• Recap of the history of excipient regulations in China
• Recent changes of regulations for excipient registration
• ChP 2020
• Regulatory trends for excipients in China
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 6 has been released with
News Uptoday
New Guidance
New MAPP Release
Audit Findings
483 Observations
- 483 of Impax Laboratories
- 483 of Ipca Labs
- 483 of Bausch & Lomb Inc
- 483 of Alexion
Warning Letters
- Marck Biosciences Ltd.
- The Compounding Shop Inc.
- Zions Rx Formulations Services LLC.
EMA Non-Compliance Reports
- Renown Pharmaceuticals Pvt. Ltd., India
- VETPROM AD, Bulgaria
- SCM PHARMA LIMITED, UK
Guest of the Month
Dr. M Damodharan - Vice President Global Quality & Regulatory
Regulations of the Month
§ 211.180 Subpart J--Records and Reports - General Requirements
§ 211.182 Subpart J--Records and Reports - Equipment cleaning & use log
Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week of July 20. This comes four months after putting all routine domestic inspections on hold due to COVID-19. In line with its update in May, the agency reiterated it will be following CDC guidelines to implement the plan safely, keeping the safety of FDA and industry staff as the top priority...
Clinical Trial Supply and Logistics Market for Pharma 2018-2028 pharmaceutica...Visiongain
For a report overview of this report please contact sara.peerun@visiongain.com
(+44 (0) 20 7336 6100) or refer to our website: https://www.visiongain.com/Report/2112/Clinical-Trial-Supply-and-Logistics-Market-for-Pharma-2018-2028
FDA’s Plan to Re-Start Routine InspectionsEMMAIntl
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, it would also be temporarily halting all domestic routine surveillance inspections. This unusual move by the agency was made to protect the health of all FDA staff and in response to the growing industry concerns about visitors to medical device facilities...
Pharmacovigilance Department Initiatives During COVID-19UN SPHS
Delivered by Dr. Abudaali Almutairi, Drug Safety Expert, Saudi Food and Drug Authority (SFDA) at the Global Forum 2020 Drug Safety and Supply Chains session.
SDL How Global Life Sciences Leaders Solve the Customer Experience PuzzleChip Gettinger
Having the right global customer experience strategy that fully integrates global product labeling interactions with real world patient care is critical for beating competitors and earning your customers’ loyalty.’
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies to be distributed in Canada. Below are some of the policies that Health Canada rolled out to prevent shortages of supplies and ensuring that safe and effective products are distributed in the market for use...
Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.
The presentation covers the following topics:
- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers
- How these systems have evolved to date to include patients’ experiences
- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:
- How and at what stage should patients be involved in HTA processes?
- What are the criteria for successful involvement of patients in HTA processes?
- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?
- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?
Impact of the Government Shutdown on Synchrogenix FDA-regulated ClientsDarshan Kulkarni
As of Dec 22nd, some 800,000 federal workers either furloughed or working without pay. Will this compromise the FDA's mission to protect public health?
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 3 has been released with
News Uptoday
New Guidelines
Audit Findings
Guest of the Month
Regulation of the Month
New Developments of Excipient Regulations in ChinaMilliporeSigma
Watch the webinar recording: https://bit.ly/2SE4DkZ
Abstract:
If you want to market your drug in China, are you aware that the excipients used in your drug need to be registered and to be compliant with the Chinese Pharmacopoeia?
Since 2017, Chinese Health Authority has published new regulations for Co-Review procedure of API, excipient and packaging material. NMPA and CDE are developing the pharmaceuticals regulations continuously. Focusing on the unique regulatory requirements for the registration of excipients, we will give you an update on the recent changes in excipient regulations, the published ChP 2020 and the regulatory trends for excipients in China.
In this webinar, you will learn:
• Recap of the history of excipient regulations in China
• Recent changes of regulations for excipient registration
• ChP 2020
• Regulatory trends for excipients in China
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 6 has been released with
News Uptoday
New Guidance
New MAPP Release
Audit Findings
483 Observations
- 483 of Impax Laboratories
- 483 of Ipca Labs
- 483 of Bausch & Lomb Inc
- 483 of Alexion
Warning Letters
- Marck Biosciences Ltd.
- The Compounding Shop Inc.
- Zions Rx Formulations Services LLC.
EMA Non-Compliance Reports
- Renown Pharmaceuticals Pvt. Ltd., India
- VETPROM AD, Bulgaria
- SCM PHARMA LIMITED, UK
Guest of the Month
Dr. M Damodharan - Vice President Global Quality & Regulatory
Regulations of the Month
§ 211.180 Subpart J--Records and Reports - General Requirements
§ 211.182 Subpart J--Records and Reports - Equipment cleaning & use log
Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week of July 20. This comes four months after putting all routine domestic inspections on hold due to COVID-19. In line with its update in May, the agency reiterated it will be following CDC guidelines to implement the plan safely, keeping the safety of FDA and industry staff as the top priority...
Clinical Trial Supply and Logistics Market for Pharma 2018-2028 pharmaceutica...Visiongain
For a report overview of this report please contact sara.peerun@visiongain.com
(+44 (0) 20 7336 6100) or refer to our website: https://www.visiongain.com/Report/2112/Clinical-Trial-Supply-and-Logistics-Market-for-Pharma-2018-2028
FDA’s Plan to Re-Start Routine InspectionsEMMAIntl
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, it would also be temporarily halting all domestic routine surveillance inspections. This unusual move by the agency was made to protect the health of all FDA staff and in response to the growing industry concerns about visitors to medical device facilities...
Pharmacovigilance Department Initiatives During COVID-19UN SPHS
Delivered by Dr. Abudaali Almutairi, Drug Safety Expert, Saudi Food and Drug Authority (SFDA) at the Global Forum 2020 Drug Safety and Supply Chains session.
SDL How Global Life Sciences Leaders Solve the Customer Experience PuzzleChip Gettinger
Having the right global customer experience strategy that fully integrates global product labeling interactions with real world patient care is critical for beating competitors and earning your customers’ loyalty.’
Centralized Translation Processes: Overcoming Global Regulatory and Multiling...Scott Abel
Presented by Inna Kassatkina at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis, IN.
Accurate translations of clinical trial documents play an important role in meeting global product demands. If not, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits. Specifically, adhering to a documented process of free and informed consent as well as the proper translation of ICFs are crucial for protecting the subjects’ human rights. Communication problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects. In this session, attendees learn to overcome the challenges of managing global content and to streamline and centralize the translation process.
* Managing Global Content: Specifically, in global clinical trials there is an overwhelming amount of information to manage. From source content creation to content management in multiple language, any life sciences professional involved in the global clinical trial process can benefit from project management approach to content management – from regulatory, financial, and efficiency perspectives.
* Streamlining Processes: Companies that are successful in managing translation of consent forms and other clinical trial materials, follow strict quality assurance procedures, be it with their on-staff translators or through a third-party translation agency. All documents are first translated, then edited, and finally proofread by experienced professional translators with clinical research background. In addition to that, translation memory tools are used, which reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds.
Final thesis presentation. Presented in May 2007 at Pratt Institute, Design Management Department by Michael Melnick, Nicole Casey and Melanie Cohen
How can Design Management help identify creative assets and strategically allocate them to make improvements for the global leather Industry?
Six Elements of the QC Process.
To learn more about the QC Process join us for a complimentary webinar ( March 29 @11am EST) where we will follow a TMF document through its life cycle from creation through inspection: Learn how TMF documents should maneuver through TMF submissions and quality checks utilizing well-developed processes, tools and metrics to ensure the TMF is ready when the inspectors come knocking.
Presented by: Jackie Morrill - Director of Clinical Operations
Register Here: http://bit.ly/2kqA6s8
Ann Rockley — Bridging Pharma Content Silos: Managing Content from Clinical t...Ann Rockley
Content is produced for clinical trials, submissions, labeling, and marketing. The content is created, recreated, and recreated throughout its lifecycle. At best case it is copied and pasted into multiple documents. Often times, the original source of the content is lost within the versions. When content changes, it must be found and updated wherever it occurs. This process is time-consuming and error-prone. Content can be interpreted differently at each stage allowing for "drift" in the message and accuracy. This slide deck shows you how you can: Envision your content as a coherent whole rather than disparate documents; develop methods for reusing content; and optimize the content creation, review, and delivery process.
Life science companies expect electronic trial master file (eTMF) projects to provide greater efficiency, improve quality, increase standardization and enhance collaboration in TMF management. Join Paragon Solutions for the second session of our TMF webinar series to gain insights on the practical factors to consider when planning a new or improved future state eTMF. We'll share industry data on eTMF drivers, and discuss our definition of a robust eTMF. You'll learn why TMF information architecture is so critical to eTMF uptake and usability, and high level considerations for systems integration/migration. Finally, we'll define the maturity framework that allows for assessment of eTMF organizational readiness, a critical baseline to successful future state eTMF planning.
This presentation describes a case study of an eTMF structure, setup, and implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
Regulatory Affairs in the Pharmacy Curriulum A Reviewijtsrd
The Indian pharmaceutical industry is expanding quickly, and there is a need of regulatory affairs specialists to meet the present demands of companies in the face of international competition. The goal of governments to protect public health has led to the development of a relatively new profession known as regulatory affairs. Pharmaceuticals, veterinary medications, medical gadgets, pesticides, agrochemicals, and cosmetics are among the industries where the government regulates the safety and effectiveness of products. And alternative treatments. The pharmaceutical firms in charge of these drugs discovery, development, testing, clinical trials, production, manufacturing, and marketingItems also want to make sure that they are providing products that are secure and beneficial to the health and welfare of the general public. legislative issuesThe international regulatory bodies and the pharmaceutical businesses are connected via specialists. It is needed that they. Akshay Kaware | Prof. Santosh Waghmare | Dr. Hemant Kamble "Regulatory Affairs in the Pharmacy Curriulum: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52279.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/52279/regulatory-affairs-in-the-pharmacy-curriulum-a-review/akshay-kaware
CMS recently announced a proposed rule for Medicaid (CMS-2482-P) that builds on current policies to help ensure that opioid prescribing is appropriate, medically necessary, and avoids adverse medical events.
CMS recently announced a proposed rule for Medicaid (CMS-2482-P) that builds on current policies to help ensure that opioid prescribing is appropriate, medically necessary, and avoids adverse medical events.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 8 has been released with the following content.
3 News Uptoday
14 New Guidance
30 Audit Findings
483 Observations
- Exemplar Lab, MA
- Genentech Inc
- Celltex Therapeutics Corporation
- APP Pharmaceuticals, LLC
- Reganeron Pharmaceuticals, Inc.
Warning Letters
- Hospira, Austarlia
- Sanjiu Medical and Pharmaceutical Co.,
- Beacon Hill Medical Pharmacy
EMA Non-Compliance Reports
- Wockhardt Limited, Nani Daman
- Fujian South Pharmaceutical, China
40 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
§ 211.186 Master production and control records
Health & Human Services - Regulatory Reform - January 2012 UpdateObama White House
In January 2011, President Obama outlined his plan to create a 21st-century regulatory system – one that protects public health and welfare while promoting economic growth, innovation, competitiveness, and job creation. Among other things, his Executive Order on Regulation said the following: Always consider costs and reduce burdens for American businesses and consumers when developing rules; expand opportunities for public participation and public comment; simplify rules; promote freedom of choice; and ensure that regulations are driven by real science. this is the January 2012 update from the Department of Health and Human Services, go here for more information:
http://www.whitehouse.gov/21stcenturygov/actions/21st-century-regulatory-system
Similar to Changing Regulatory Landscape of 2017 (20)
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
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.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
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/
How many patients does case series should have In comparison to case reports.pdf
Changing Regulatory Landscape of 2017
1. http://vistaar.makrocare.com/ 01 February 2017
Dealingwithcurrentandupcomingbiopharmaregulationshaveneverbeenas
tough and challenging as these days. We have lot of regulatory intelligence
tools in the market simultaneously never been so simple to handle with most
frequent changing regulatory policies, amendments or requirements of the
authorities. Taking off many guidelines to be amenable across the world,
various drug regulatory authorities released guidelines or policies.
In this Newsletter, we have compiled and simplified some of these new
policies, revisions, regulatory amendments from registration, labeling, safety
reporting, renewal, publishing /eCTD submission of last year and forthcoming
years for our subscribers:
Changing Regulatory Landscape of
preceding and forthcoming Years
Global Drug Regulatory Intelligence
In a notice posted to its website, Health Canada
gave advance warning that the agency is
considering an eCTD filing requirement, or eCTD
mandate, that would take effect as early as
January 1, 2018.
The eCTD format filing requirement would apply
to the following regulatory activity types:
• New Drug Submission (NDS)
• Supplement to a New Drug Submission SNDS)
• Abbreviated New Drug Submission (ANDS)
• Supplement to an Abbreviated New Drug
Submission (SANDS)
Authority
Health Canada
Regulatory Change or a rule
2. http://vistaar.makrocare.com/ 02 February 2017
The South African
Medicine Control
Council (MCC)
Labeling
Health Canada has been accepting regulatory
submissions in eCTD format since 2004
however reaching towards a common
submission intake process, as well as intending
to stay aligned with other regulatory authorities,
Health Canada is revising the existing
requirements.
October, 2016: The South African Medicine
Control Council (MCC) updated its Specification
for electronic Common Technical Document
(eCTD) Regional-Module 1 intended to provide
requirements to applicants wishing to submit
applications for the registration of medicines in
eCTD format.
This document specifies Module 1 of the
electronic Common Technical Document
(eCTD) for South Africa (“ZA”). MCC has
deadlinetill30April2017,forboththeversionsof
South African Module 1 specifications for eCTD.
If by chance the eCTD submissions made after 1
May 2017 do not comply with the South African
Module 1 specification for eCTD V2.0, the
applications will not be accepted.
The Saudi Food
and Drug Authority
(SFDA)
Baseline eCTD Submission mandatory for any
new regulatory activities (initial registration,
renewal or variation etc.), from January 2017.
United States food
and drug
administration
(USFDA)
Starting from May, 2017, all new Drug Master File
(DMFs), all documents submitted to existing
DMFs, must be submitted in an electronic
Common Technical Document (eCTD).
FDA eyes mandatory eCTD format for certain
submissions types beginning May 5, 2017,
submission types namely,
New Drug Applications (NDA),
Abbreviated New Drug Applications (ANDA),
Biological License Applications (BLA) and
Master Files must be submitted in the eCTD
format. However, for all commercial
Investigational New Drug submissions (IND), the
deadline is set for May 5, 2018.
The China Food
and Drug
Administration
(CFDA)
New packaging requirements: From July 2017
cosmetic products must be labeled with the new
label. The products and packaging must not be
labeled with the QS mark. Cosmetics
manufacturers could mark their registered
products with the “old ” label on the packaging till
30th June 2017. Even if, the products which are
already packaged can be made available in the
market till the expiration date after which they
needtocomplywithnewpackagingrequirements.
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Health Canada
Therapeutic Goods
Administration
(TGA)
The South African
Medicine Control
Council (MCC)
Authority
Releases a plain language labeling guidance. For non-prescription products, the Regulations
apply as of June 13, 2017; emphasizing the safety through labeling for Prescription drugs,
Health Canada has released a guidance document for Plain Language Labeling which came
into effect from June 13, 2015.
New labeling requirements for medicines supplied in Australia. These changes will be
implemented over four years from 31 August 2016.
The announcement was made following extensive consultation on changes to Therapeutic
Goods Order No. 69 - General requirements for labels of medicines (TGO69).
Labeling requirements have been split into two new labeling Orders:
• TGO 91 - Standard for labels of prescription and related medicines (TGO91)
• TGO 92 - Standard for labels of non-prescription medicines (TGO92)
This split was applied to better consider the different risk levels for prescription and
non-prescription medicines and also to improve overall readability.
TGO 91 and TGO 92 are registered on the Federal Register of Legislation and a new guidance
document is available to assist you in complying with the new requirements.
These Orders will come into effect on 31 August 2016, which will start the four year transition
period.
Transition period - what sponsors need to do
The four year transition period for these changes will start on 31 August 2016 and end on 31
August 2020. During this time, you can choose to comply with the old labeling requirements
under TGO 69 or the new labeling requirements under TGO 91/92 (whichever applies).
Labels must fully comply with all requirements of either the old or the relevant new Order. A
label cannot selectively comply with parts of multiple Orders.
After the 4 year transition, all medicines must comply with either TGO 91 or TGO 92.
The Pharmacy and
Poisons Board
(PPB)
The PPB revised its Guidelines for Conduct of Clinical Trials in Kenya. The document is
intended to provide guidance on the format and contents of application for authorization to
conduct clinical trials in Kenya, the amendments to clinical trial application and the
declarations at the end of a clinical trial and the revised guideline was effective from
September, 2016.
Regulatory Change or a rule
