A brief introduction of the outsourcing methods in Pharma Supply Chain, Types of Outsourcing, Framework to decide correct outsourcing partner, factors to consider while selecting a partner, Process of outsourcing and Outsourcing models.
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
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Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
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Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
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M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
Essential Documents For the Conduct of Clinical TrialClinosolIndia
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The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
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Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
Â
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
Essential Documents For the Conduct of Clinical TrialClinosolIndia
Â
The conduct of a clinical trial involves the generation and maintenance of various essential documents to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines. These documents serve as a record of the trial and provide evidence of the study's conduct, integrity, and participant protection. Here are some essential documents commonly required for the conduct of a clinical trial
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Â
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Pharmaceutical Competitive Intelligence: An Essential Pill in the Pharmaceuti...RNayak3
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Discover how competitive intelligence in pharma generates insightful data highlighting the capabilities of pharma businesses to meet patient requirements.
Competitive Intelligence: An Essential Pill in the Pharmaceutical KitRNayak3
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Discover how competitive intelligence in pharma generates insightful data highlighting the capabilities of pharma businesses to meet patient requirements.
Competitive Intelligence: An Essential Pill in the Pharmaceutical KitRNayak3
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Discover how competitive intelligence in pharma generates insightful data highlighting the capabilities of pharma businesses to meet patient requirements. Source: https://www.wns.com/perspectives/articles/articledetail/123/competitive-intelligence-an-essential-pill-in-the-pharmaceutical-kit
Competitive Intelligence: An Essential Pill in the Pharmaceutical KitRNayak3
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Discover how competitive intelligence in pharma generates insightful data highlighting the capabilities of pharma businesses to meet patient requirements.
Contents
- The journey to procurement excellence
- How world class organizations reduce costs
- How world class organizations mitigate risks
- IBM: The role and impact of technology in world class procurement organizations
- Summary
- Recommended reading
- Surviving and thriving with world class supply management
- An executive guide for managing risk in global sourcing
- Achieving spend visibility: benefits, barriers, and best practices
2018 Trends in Global Market Device Strategy Tony Freeman
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This presentation covers:
* Size of the global device market
* Industry growth rate
* 30 largest OEMs and their percentage of the market
* Trends driving the re-design of medical device product lines
* Consolidation and its effects on the supply chain
* Growth of global contract manufacturers
* Four essentials for medical device contract manufacturers to expand in this environment
History of jidoka, TPS, concept, role, principle and steps of jidoka. Tools of jidoka, Andon, Andon cord, Fixed-position stop, Poke-yoke with a pharmaceutical example
human resource management
A presentation on the different labour laws in India. It includes the need, role, principles of labour law in emplyee management and Human resource management. This presentation specially focuses on the child Labour Law (1986)
a detailed presentation on face care, skin care and cosmeceuticals. also includes type of face care, famous brands in India, in the world, total market, distribution channel, online marketing of cometics and future of face care.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
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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.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
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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.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
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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.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
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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.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
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The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The Importance of Community Nursing Care.pdfAD Healthcare
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NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
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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.Â
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 doctorsâ 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 laboratoryÂ
 to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Global launch of the Healthy Ageing and Prevention Index 2nd wave â alongside...ILC- UK
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The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
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)
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
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According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
2. Outsourcing
The strategic use of
outside resource to
perform activities that
were traditionally
handled by internal
staff and resource.
Also known as
facilities
management.
The current
mantra of
pharmaceutical
industry.
3. Reasons to Outsource
Shortens cycle time
Decrease required inventory
Reduces expenses
Increase productivity
Increase profitability
Increase consumer retention
4. Advantages and Disadvantages
Advantages
⢠Focus on other business aspects
⢠Minimize overall cost
⢠Meet customer demand
⢠Focus on your product
⢠More flexibility
Disadvantages
⢠Unanticipated cost
⢠Potential for setbacks
⢠Integration difficulties
⢠Quality suffers
⢠Choosing wrong outsourcing
partner
8. Framework to decide correct outsourcing partner
High Donât outsource to
such supplier
Critical/ very high
value components
Low Non critical/low
value component
Highly critical/high
value components
Low High
Distancefromorganizationorleadtime
Supplier capability or cost advantage
9. People
Technology
Process
Factors to be considered
â˘Companyâs financial stability
â˘Business experience
â˘Reputation
â˘Values and ethics
â˘Chemistry and compatibility
â˘Technology capabilities
â˘Security
â˘support
â˘Capability
â˘Commitment to continue
improvement
â˘Growth potential
12. Outsource models
⢠Hiring of dedicated
team at third party.
⢠Used when, there is
shortage in workspace
and difficulty in
personnel requirement.
Staff
augmentation:
⢠Specific task or
department are handed
to third party.
⢠Used when company
wants to concentrate
on core activities
rather than non-core
Out-tasking
13. Outsource models
⢠Specific projects
are out sourced.
Project based
⢠Day to day
management
responsibilities are
outsourced.
Managed
services
⢠Third party builds
the facility as per
companyâs
requirement and
specifications.
Build operate
and transfer
14. Risk of using a third party
The process is broken
Reduced customer/supplier
contact
Leakage of sensitive data and
information
Ineffective contracts
Loss of supply chain visibility
Negative reputational impact