Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
TCD MENA was a Main Sponsor of Armed Forces College of Medicine GCP Workshop that was held on 27,28th FEB 2017. Dr. Hanaa Abdel-Maguid (Managing Director - TCD MENA) was an instructor in the GCP Workshop where she presented a session entitled "Sponsor/CRO responsibilties.
TCD MENA CRO is an affiliate of TCD Global headquartered in South Africa, providing end-to-end clinical research services: Regulatory Affairs, Clinical Operations, Project Management, Pharmacovigilance, Data Management, Biostatistics & Medical Writing.
TCD MENA Team has extensive clinical research experience for managing global clinical trials with sites in Egypt and MENA region; also experienced in managing bioequivalence studies accepted by WHO, FDA & EU. The team has worked in different therapeutic areas including Oncology, Hepatology, Internal Medicine, Gynecology, chronic diseases with strong relationships with KOLs across Egypt & MENA region.
TCD MENA Team understands the needs of sponsors in a time when there are significant economic constraints globally. Part of our mission will be to convert these sponsor needs into innovative solutions to support R&D objectives in terms of Quality, Time & Cost flexibility.
TCD MENA looks forward to demonstrate its capabilities and commitment to achieve your goals as the start of a long term solid partnership with your respectful organization. TCD Global will remain responsive to global trends and changing customer needs.
Sense of urgency, lessons learned, organizational alignment, team approach, training and an increasing engineering and statistical capability at CDER FDA can be expected to facilitate a move by industry towards continues manufacturing, FDA’s current emphasis on ‘statistical confidence’, Process Validation Guidance 2011, is likely to highlight certain issues (e.g., special causes) within current batch processing; these observation will need to be addressed in an appropriate risk-based manner
Ensuring that pragmatic consideration for specifications & control (intended use) is essential and importance of pragmatic decisions should not be forgotten (e.g., as in case of Design Space Vs. SUPAC), Effective regulatory communication (considering the engineering and statistical emphasis) will be crucial for ensuring regulatory uncertainty is managed in a timely manner,
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
TCD MENA was a Main Sponsor of Armed Forces College of Medicine GCP Workshop that was held on 27,28th FEB 2017. Dr. Hanaa Abdel-Maguid (Managing Director - TCD MENA) was an instructor in the GCP Workshop where she presented a session entitled "Sponsor/CRO responsibilties.
TCD MENA CRO is an affiliate of TCD Global headquartered in South Africa, providing end-to-end clinical research services: Regulatory Affairs, Clinical Operations, Project Management, Pharmacovigilance, Data Management, Biostatistics & Medical Writing.
TCD MENA Team has extensive clinical research experience for managing global clinical trials with sites in Egypt and MENA region; also experienced in managing bioequivalence studies accepted by WHO, FDA & EU. The team has worked in different therapeutic areas including Oncology, Hepatology, Internal Medicine, Gynecology, chronic diseases with strong relationships with KOLs across Egypt & MENA region.
TCD MENA Team understands the needs of sponsors in a time when there are significant economic constraints globally. Part of our mission will be to convert these sponsor needs into innovative solutions to support R&D objectives in terms of Quality, Time & Cost flexibility.
TCD MENA looks forward to demonstrate its capabilities and commitment to achieve your goals as the start of a long term solid partnership with your respectful organization. TCD Global will remain responsive to global trends and changing customer needs.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The notion ‘by design’, in the phrase ‘Quality by
Design’, conveys an intention to deliver a product
or service with a pre-defined ‘quality’ so as to satisfy
intended customers. When the quality of a medicinal
product is considered, customer satisfaction
is often not easily measured. Therefore, regulatory
approval is important, and, it may be viewed as a
surrogate for confidence and satisfaction patients
and their physicians perceive.
This SWISS PHARMA presentation by
the author on 25 May 2012, in Basel, explored the
potential role of mathematical modeling tools, categorized
as Chemometrics, Pharmacometrics and
Econometrics, in improving regulatory communications
on ‘quality by design’. This article provides a
summary of arguments outlined during this presentation.
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
This presentation gives the details about career opportunities in clinical research, clinical research courses available in India and clinical research training.
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Outsourcing in Drug Development: The Contract Research (Clinical Trial) MarketMarketResearch.com
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years. Contract Research Organizations (CROs) and other entities can expect growing demand for their services.
The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
Role of CRO’s in Medical Innovation and Drug DevelopmentJohn Douglas
Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consistent attempts on a global level. Therefore, when the medical equipment and pharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to the market, that is the time when they also need partners who are able to collaborate and assure them effortless development and service delivery.
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
Pharma Focus Asia, the leading Pharma Magazine in the industry, provides the latest issue 29 that discusses latest trends happening in the pharma industry. Explore our latest issue to enhance your knowledge. Check our Digital Magazine here: https://goo.gl/FHDDtt
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “7th Annual Clinical Trials Summit 2016” The conference will Be held on 14th May 2016, The Lalit Hotel, Mumbai, India.
Following our past six highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “7th Annual Clinical Trials Summit 2016” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “7th Annual Clinical Trials Summit 2016”. I wish and pray that all our efforts will be beneficial to our industries folks at large.
CONFIRMED SPEAKERS FROM :- Takeda Pharmaceuticals (UK), Clinical Research & Development, Cadila, Sanofi Aventis, Johnson & Johnson, GNH India, Clintech India, Boehringer Ingelheim, Reliance Life Sciences, Abbott, Glenmark Pharmaceuticals, Sanofi, Nishith Desai Associates, Novartis, Tata Consultancy Services, Janssen India (Pharmaceutical companies of Johnson & Johnson), SIRO Clinpharm, and few more..
CONFERENCE BOOKING DETAILS:-
• Standard Price (10th April 2016):- 1 or 2 Delegates - (INR 7,000 + Tax (14.5%) per delegate)
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14.5%) per delegate)
• Group Discounts – 5 and above Delegates - (INR 5,500 + Tax (14.5%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you.
PS: - Please refer your friends or colleagues by forwarding this email to anyone you think may benefit from it.
Best Regards,
Deepak Raj
Delegate and Sponsorship Sales
Virtue Insight
Gsm - + 91 9171350244
Tel - + 91 44 65515693
Skype - edeepakraj143
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The notion ‘by design’, in the phrase ‘Quality by
Design’, conveys an intention to deliver a product
or service with a pre-defined ‘quality’ so as to satisfy
intended customers. When the quality of a medicinal
product is considered, customer satisfaction
is often not easily measured. Therefore, regulatory
approval is important, and, it may be viewed as a
surrogate for confidence and satisfaction patients
and their physicians perceive.
This SWISS PHARMA presentation by
the author on 25 May 2012, in Basel, explored the
potential role of mathematical modeling tools, categorized
as Chemometrics, Pharmacometrics and
Econometrics, in improving regulatory communications
on ‘quality by design’. This article provides a
summary of arguments outlined during this presentation.
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
This presentation gives the details about career opportunities in clinical research, clinical research courses available in India and clinical research training.
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Outsourcing in Drug Development: The Contract Research (Clinical Trial) MarketMarketResearch.com
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years. Contract Research Organizations (CROs) and other entities can expect growing demand for their services.
The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
Role of CRO’s in Medical Innovation and Drug DevelopmentJohn Douglas
Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consistent attempts on a global level. Therefore, when the medical equipment and pharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to the market, that is the time when they also need partners who are able to collaborate and assure them effortless development and service delivery.
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
This presentation was hosted by Gerry Jeffcott from 3Sixty Public Affairs, who was joined by two pharmaceutical policy researchers who have conducted analyses of Canada’s access performance over time and in comparison with other countries.
The session began with an overview of each of the elements of the Canadian review and approval process by our moderator. After that, the session explored each agency’s performances in terms of supporting efficient access to needed new medicines. We will also compare Canada with other similar countries to determine how we fare internationally in terms of gaining access.
The presentation includes an interactive question and answer session.
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
Pharma Focus Asia, the leading Pharma Magazine in the industry, provides the latest issue 29 that discusses latest trends happening in the pharma industry. Explore our latest issue to enhance your knowledge. Check our Digital Magazine here: https://goo.gl/FHDDtt
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “7th Annual Clinical Trials Summit 2016” The conference will Be held on 14th May 2016, The Lalit Hotel, Mumbai, India.
Following our past six highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “7th Annual Clinical Trials Summit 2016” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “7th Annual Clinical Trials Summit 2016”. I wish and pray that all our efforts will be beneficial to our industries folks at large.
CONFIRMED SPEAKERS FROM :- Takeda Pharmaceuticals (UK), Clinical Research & Development, Cadila, Sanofi Aventis, Johnson & Johnson, GNH India, Clintech India, Boehringer Ingelheim, Reliance Life Sciences, Abbott, Glenmark Pharmaceuticals, Sanofi, Nishith Desai Associates, Novartis, Tata Consultancy Services, Janssen India (Pharmaceutical companies of Johnson & Johnson), SIRO Clinpharm, and few more..
CONFERENCE BOOKING DETAILS:-
• Standard Price (10th April 2016):- 1 or 2 Delegates - (INR 7,000 + Tax (14.5%) per delegate)
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14.5%) per delegate)
• Group Discounts – 5 and above Delegates - (INR 5,500 + Tax (14.5%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you.
PS: - Please refer your friends or colleagues by forwarding this email to anyone you think may benefit from it.
Best Regards,
Deepak Raj
Delegate and Sponsorship Sales
Virtue Insight
Gsm - + 91 9171350244
Tel - + 91 44 65515693
Skype - edeepakraj143
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.
7th Pharmacovigilance 2014 “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor / delegate for our upcoming conference. The “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management” at 7th Pharmacovigilance 2014 on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.Contact:-Tel: +91 9677590192 Email: dinesh@virtueinsight.co.in
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
Inhalation & Respiratory Drug Delivery SummitDiogo Ribeiro
The IRDD Summit will focus on the challenges of bringing respiratory products to market and innovative aerosol science, including modelling and toxicology. Presentations will also feature key case studies on the latest trends in inhalation devices, from inhaled insulin to gene therapy to overcome lung and pulmonary conditions, such as COPD, asthma and cystic fibrosis.
Project description future challenges and focus group on pharmaceutical suppl...Dr. Hannes Hofmann
Together with Professor Dr. Constantin Blome (University of Sussex, UK) and Professor Dr. Michael Henke (Fraunhofer IML Dortmund/TU Dortmund, Germany), we conduct an international study on the future of pharmaceutical supply chains.
Based on your personal expertise and experience, we chose to contact you to share your judgments about how certain trends over the next 10 years will affect pharmaceutical supply chains.
With this research project we aim to achieve two goals:
1) Based on expert judgments we will compile a management report illustrating key challenges and prospects for pharmaceutical supply chains in 2025.
2) A Focus Group of practitioners and academia will be established to share expert views on upcoming trends and to develop joint solutions to master upcoming challenges.
Of course, your personal and your company’s identity will not be disclosed and all information will be aggregated.
Asia Pacific Drug Formulation & Bioavailability Congress Murahari Nanda
OMICS International invites all the participants across the globe to attend “Asia Pacific Drug Formulation & Bioavailability Congress” september 05-07,2016 Beijing, China. Drug Formulation 2016 is a remarkable event which brings together a unique and International mix of large and medium Pharmaceutical companies / industries, leading universities and research institutions making the conference a perfect platform to share experience, foster collaborations across industry and academia, and evaluate emerging technologies across the globe.
OMICS International Organizes 1000+ Conferences Every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 700+ Open access journals which contains over 30000 eminent personalities, reputed scientists as editorial board members
Oral Drug Formulation Innovations 2014Simon Curtis
The Oral Drug Formulation Innovations Summit will examine and showcase the industry's latest formulation and delivery technologies for enhancing solubility and maximizing bioavailability. Leading global formulation experts in both industry and academia will share unique strategies on how to effectively develop poorly soluble drugs into scientifically unique, compliant, patient-centric formulations. Additionally, innovative strategies to significantly reduce product development timelines will be shared, and the latest regulatory requirements will be discussed.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
Similar to CRSIC Seminar Brochure 15 October 2016 (20)
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
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.
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
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..
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.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
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.
1. CRS INDIAN CHAPTER
CONTROLLED RELEASE SOCIETY-
INDIAN CHAPTER (CRS-IC)
ORGANIZES
ONE DAY NATIONAL SEMINAR
ON
CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS -
ADHERENCE TO REGULATORY REQUIREMENTS
Saturday, 15th October 2016
Supported By
THE SCITECH CENTRE
MUMBAI
VENUE :
SCITECH CENTRE
7, Prabhat nagar, Jogeshwari (W),
Mumbai-400 102,
Maharashtra, India.
Website: www.crsic.org
Controlled Release Society (CRS Inc) with over 4000 members worldwide is
global scientific society. It is an international organization for the
promotion and development of novel drug delivery systems, with the
headquarters in Minneapolis, Minnesota, USA and liaison offices in Geneva,
Switzerland and Kawasaki, Japan. The Indian Local Chapter of Controlled
Release Society (CRS-IC) was established in 1994 with headquarters at PERD
Centre, Ahmedabad and regional office at SciTech Centre, Jogeshwari, Mumbai.
The mission of CRS-IC is to promote education, create awareness and to
encourage scientific research towards the creation of intellectual wealth in the
area of drug delivery systems in India. The CRS-IC works with the objective of
providing an excellent forum to advance the science and technology of new
chemical and biological delivery systems. It plans and organizes regularly symposia
and workshops that focus on advances in technology and business potential of
Novel Drug Delivery Systems (NDDS). These activities have created increased
awareness regarding the significance of novel drug delivery systems and
appropriate utilization of such technology by both academic institutions and
Pharmaceutical industry.
The CRS-IC offers opportunities for business collaborations with technology driven
pharmaceutical manufacturers and allied industry. It provides a platform for
interaction with emerging drug delivery designers and biotechnology companies,
pharmaceutical excipients and equipment manufacturers and allied suppliers to
expose their concepts, technological products and services. CRS-IC offers travel
grants to students and young scientists to enable them to participate and present
their research work at international platforms.
2. THEME OF THE SEMINAR
The interest in Novel Drug Delivery Systems (NDDS) has increased due to advancement and
availability of variety of technologies to deliver conventional drugs in novel dosage forms.
However the clinical approach and the regulatory requirements continue to provide a
major challenge. Developing NDDS for an existing molecule is a part of the Research and
Development portfolio for most Pharmaceutical Companies, in a quest of delivering
therapeutic agents with improved efficacy and minimum side effects.
This seminar will provide a forum for academic and industry researchers, clinical experts
and regulatory professionals to discuss the latest scientific and clinical developments for
drug delivery systems, as well as the perceived regulatory concerns and challenges
regarding their submission and approval. Delivery Systems presented will cover oral,
transdermal, nasal and injectables. Some non-clinical opportunities with respect to
modelling and simulation, to assist with pharmaceutical research and regulatory
submissions, will also be discussed.
WHO WILL BENEFIT
SPEAKERS
Clinical approach for non solid oral drug delivery system
Mr. Sushrut Kulkarni
Senior Vice-President and Head Pharmaceutical Technology Center , Zydus Cadilla,
Ahmedabad, India
Clinical trials of oral drug delivery systems – design requirements
Dr. Shravanti Bhowmik
Associate Vice President- Clinical Research
Sun Pharma Advanced Research Company, Mumbai, India
Clinical development strategies for cancer nano – therapeutics
Dr. Mahesh Paithankar
Senior Vice-President, NDDS, Intas Pharmaceuticals Ltd., Ahmedabad, India
Nasal drug delivery system: scientific, clinical and regulatory requirements for
USA market
Dr. Ganesh Jadhav
General Manager, Product Innovation
Sun Pharmaceutical Industries Ltd., Vadodara, India
Applying gastro plus PBPK modeling & simulation to assist with pharmaceutical
research and regulatory submissions
Mr. John Di Bella
Vice President – Marketing & Sales at Simulations Plus, Inc., California, USA
Executive Management
Product Development Team
Regulatory Affairs Managers
Clinical Researchers
Consultants / Service Providers
Compliance Information Managers
Pharmacokinetic Experts
Research students
3. WHAT THE SEMINAR WILL COVER
Mr. Sushrut Kulkarni an inventor with a vast experience in development of
practically all dosage forms and holds around 143 patent applications filed globally
will cover “Clinical approach for non solid oral drug delivery system” where he will
discuss the steps taken by FDA under “Regulatory Science Initiatives” to propose
Novel Bioequivalence study designs for complex solid oral and non-solid oral drug
delivery systems. These recommendations have greatly helped Industry to
understand FDA Perspective and to focus on critical aspects of development.
Dr. Shravanti Bhowmik with her expertise in Clinical Development will speak
about the major concerns of efficacy and safety with new oral drug delivery
system which may require extensive clinical trials or preclinical studies. A case
study of an oral controlled release product that was clinically developed to a stage
of marketing approval will be discussed. The topic of her presentation is “Clinical
trials of oral drug delivery systems – design requirements”
Dr. Mahesh Paithankar an expert on development of anticancer drug delivery
system will cover “Clinical Development strategies for cancer nano – therapeutics”
providing a detailed discussion with appropriate case studies related to nano-
therapeutic drug delivery systems on the key strategic aspects of clinical program
like expected outcome, trial design, selection of primary endpoint, type of trial,
selection of appropriate listed Drug for 505(b)(2) program etc.
Plan now to attend this one day seminar as it is a rare opportunity to learn from the key Industry experts on today’s hot topics.
Dr Ganesh Jadhav responsible for product innovation will cover “Nasal Drug
Delivery System: Scientific, Clinical and Regulatory Requirements for USA Market “
This non-traditional drug delivery route, offers a unique value proposition for drug
developers to launch new products for the treatment of a range of acute and
chronic conditions. The presentation will provide a comprehensive view of various
intranasal drug delivery technologies available in the market as well as in the
development. The scientific, clinical and regulatory requirements relevant for the
US market concerning ANDA and 505(b)(2) NDA products will be discussed
extensively.
Mr. John Di Bella a biomedical engineer will be speaking on “Applying Gastro Plus
PBPK modelling & simulation to assist with pharmaceutical research and
regulatory submissions”. Physiologically-based pharmacokinetic (PBPK) models
can be parameterized using a combination of in silico, in vitro, and in vivo data,
and their use, coupled with mechanistic absorption modelling (MAM), continues
to increase within the pharmaceutical and generic industries as this technology
helps to reduce R&D costs and regulatory burden. The focus of this presentation
will be to discuss several case studies where GastroPlus™ modelling & simulation
results were submitted to regulatory agencies to support waiver requests.
4. SCIENTIFIC COMMITTEE
Dr. Parizad Elchidana Chairperson
Dr. Vandana Patravale Member
Dr. Prajakta Dandekar Jain Member
ORGANISING COMMITTEE
Dr. H. L. Bhalla President Emeritus
Dr. Anisha Pargal Acting President
Dr. Vandana Patravale Vice President
Dr. Ganga Srinivasan Secretary
Dr.Hitesh Doshi Treasurer
Dr. Munira Momin Member
Dr. Sujata Sawarkar Member
Dr.Parizad Elchidana Invited Member
Dr. Prajakta Dandekar Jain Invited Member
Dr. Munira Momin Chairperson
Mr. Ajit Kanetkar Co-chair
Dr. Ganga Srinivasan Co-chair
Dr. Hitesh Doshi Member
Dr. Sujata Sawarkar Member
Dr. Ratnesh Jain Member
Dr. Anil Pethe Member
PATRONS
Mr. Pankaj Patel Mr. Dilip Sanghvi
Mr. Ajit Singh Mr. Kirti Patel
Mr. Himadri Sen Mr. Amarjit Singh
Dr. Kamlesh Oza Dr. F. V. Manvi
Dr. Anisha Pargal Dr. Amrita Bajaj
Dr. H. L. Bhalla Dr. Manish Nivsarkar
Dr. Padma Devarajan Dr. Kamalinder Singh
Dr. Vandana B. Patravale Mr. Harish Shah
Dr Kiran Marthak Board Member and Global Head of Clinical
Development- Lambda Therapeutic Research Ltd.
Dr. Indrani Banerjee Senior Manager, Academy for Clinical Excellence,
Mumbai
Ms. Chandrika Arora Founder & CEO , QMATRA Services LLP
Dr. Hrishikesh Kulkarni Senior Manager - Medical Services, Glenmark
Pharmaceuticals Ltd.
Mr. Naveen Sharma Chief Operation Officer, Cliantha Research Limited
EXECUTIVE COMMITTEE
ADVISORY COMMITTEE
5. Category
Non- Members
(by 10th October 2016)
Members
(by 10th October 2016)
Students 750 INR 500 INR
Academicians 1000 INR 750 INR
Industry 2000 INR 1000 INR
Foreign Delegates: Students 400 USD 300 USD
Foreign Delegates: Academicians 600 USD 500 USD
Note: Spot Registration subject to availability; Registration fee is inclusive of Service Tax
• Please fill the attached Registration Form and post it along with the Bank
Draft/Cheque with your name written at the back of draft/cheque.
• Kindly mention ‘CRS Registration’ in bold letter on the envelope carrying the
registration form.
• Register at the earliest to avoid last minute disappointment due to space
constraints.
• Students are requested to enclose a letter from the head of institution certifying
their student status.
• Photocopies of the Registration Form may be used.
• No refund of Registration Fee in case of cancellation.
Payment Mode
Demand draft to be made payable at Mumbai in favor of:
Controlled Release Society - Indian Chapter
Mail the Registration Form and Fee to:
Prof. Vandana B. Patravale
A-255, Department of Pharmaceutical Sciences and Technology
Institute of Chemical Technology, Matunga (East), Mumbai-400 019
Email ID: patravale.vb@gmail.com
ONE DAY NATIONAL SEMINAR ON
CLINICAL APPROACH FOR DRUG DELIVERY SYSTEMS -
ADHERENCE TO REGULATORY REQUIREMENTS
Saturday, 15th October 2016
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7, Prabhat nagar, Jogeshwari (W),
Mumbai-400 102, Maharashtra, India.
Online membership application form: http://goo.gl/forms/cMfIfXgZug
For more details on membership visit www.crsic.org/
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