The prospects of clinical research, especially delivering the market driven worldwide clinical research trails , including international bioequivalence studies, started as a pleasant dream in India in the early 2000s. It was ascertained by many experts that by 2012, India would be all set emerge as a global center of excellence for clinical trial.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
Mylan is a global pharmaceutical company committed to set new standards in healthcare and providing 7 billion people access to high quality medicines available to everyone who needs them.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
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.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
Mylan is a global pharmaceutical company committed to set new standards in healthcare and providing 7 billion people access to high quality medicines available to everyone who needs them.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
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.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
Being Smart About Global vs. Local During Clinical TrialsScott Abel
Presented by Don DePalma at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
As drug development expands globally, pharmaceutical project managers need to master management techniques, tools, and measures that transcend language, cultural, and geopolitical barriers. Industry leaders need to employ new technologies allow their global team members to collaborate better and to manage critical information on local, international, and global levels.
Pharmaceutical and other life sciences companies selling their products internationally typically adapt the offer, the product itself, the language, the website, the marketing collateral, its way of selling, how it delivers the product, and who supports it to the needs of doctors and other consumers in their target markets.
This presentation will outline the need, best practices, and enabling technologies for managing this critical function.
Presentation on 'Clinical Trials in India and subsequent opportunities provided by the Indian based Research and Training Organization - Syncorp in India' - Seminar provided @ Tirupati Campus of Syncorp.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
Appalla Venkataprabhakar and I presented this at the Oracle\'s Annual Clinical Development and Safety Conference 2010 at Hyderabad, India on 6th October 2010.
SYNCRETIC CLINICAL RESEARCH SERVICES PVT. LTD., is an ISO-certified CRO hybrid providing excellent end-to-end clinical research services across all domains since 2014. We have successfully completed multiple trials in various therapeutic areas for both Indian and Global Sponsors.
Currently, India is one of the top countries where clinical research companies are planning to invest over the next 5-6 years. The Indian government had also proposed a 10-year Tax Holiday on R&D investments – a move to attract more Global Sponsors from the Clinical Research Industry. India has also become the favoured destination ahead of other competing countries like Israel, Philippines, Canada, China, Ireland & Russia in terms of Overall Climate (Gartner Report, January 2003). The Indian sub-continent is also a powerhouse in research and development boasting of over 80 experienced CROs offering services from Phase I to IV trials. With 4,216 hospitals and rapidly increasing stand-alone investigators serving at sites for clinical trials, India is emerging as one of the fastest recruiters of subjects across the world. The large patient pool is also a significant contributor towards achieving these milestones.
A new set of rules in place since 2019 is beginning to make India the favourite among the big pharma giants to conduct clinical trials in India. India ranks among top five destinations for clinical trial sites and numerous big global studies are now being carried out in India – especially post the Covid pandemic. In 2021, India approved over 100 global clinical trials, this being the highest number since 2013. India has also enacted the New Drugs and Clinical Trials (NDCT) rules in March 2019 wherein a lot of accommodation is being provided to enrich the clinical research activities in the country. One of the prime reasons for global attraction is quality services at reduced costs. India is still 60% cheaper than the U.S. when it comes to conducting end-to-end clinical trials. India also has numerous world class hospitals as trial sites: 1,762 sites and counting. Also, it is equipped with about 4000+ ICH-GCP trained investigators.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
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.
Although other departments of the government shall look after market completion, polices etc. BMRC is going beyond jurisdiction to create an oligopoly situation of three brands of vaccine and depriving the nation from an own successful research. Bangladesh could be proud of global standard research by a local company.
India Urology Devices Market [2029]: Navigating Opportunities and ChallengesKumar Satyam
According to the TechSci Research report titled “India Urology Devices Market Industry Size, Share, Trends, Competition, Opportunity, and Forecast, 2019-2029,” the India Urology Devices Market is poised for significant growth. The market, valued at USD 1.10 billion in 2023, is projected to grow at a compound annual growth rate (CAGR) of 5.10% through 2029. This growth is driven by various factors, including collaborations and partnerships among leading companies, the rising prevalence of chronic diseases, and the increasing demand for advanced urology devices. This comprehensive report will delve into the market dynamics, recent trends, drivers, competitive landscape, and benefits of the research report, providing a detailed analysis of the India Urology Devices Market.
Collaborations and Partnerships
Collaborations and partnerships among leading companies are crucial in driving the growth of the India Urology Devices Market. These strategic alliances enable companies to merge their expertise, strengthen their market positions, and offer innovative solutions. By combining resources, companies can enhance their research and development capabilities, expand their product portfolios, and improve their distribution networks.
Rising Prevalence of Chronic Diseases
The increasing prevalence of chronic diseases is a significant driver for the demand for urology devices. Chronic conditions such as diabetes, hypertension, and heart disease often lead to urological complications, necessitating the use of advanced urology devices for diagnosis, treatment, and ongoing care. For instance, diabetes is a leading cause of kidney disease, and managing urological complications related to diabetes requires devices like dialysis machines, catheters, and stents.
Government Initiatives and Guidelines
The Indian government has implemented several guidelines and initiatives to address the growing burden of urological diseases. For example, the Urological Society of India's guidelines for benign prostatic hyperplasia/obstruction (BPH/BPO) advocate the use of surgical treatments, including advanced laser devices. These guidelines are expected to propel the adoption of urology devices during the forecast period.
Top 10-clinical-research-and-pharma-companies-in-maharashtraRadhika Nagare
The clinical trial industry is gaining continuously a positive metamorphosis in India. Now the clinical trial processes are being viewed as drug discovery rather than drug development destination only. At present, several companies are looking at the innovation. And rise of these companies have led to many more openings for clinical research job in Pune and India as a whole.
Role & responsibilities of a clinical research coordinatorRadhika Nagare
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Pharmacovigilance (gpv p) training in india Radhika Nagare
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
Top 10 clinical research and pharma companies in pune Radhika Nagare
The clinical trial industry is gaining continuously a positive metamorphosis in India. Now the clinical trial processes are being viewed as drug discovery rather than drug development destination only. At present, several companies are looking at the innovation. And rise of these companies have led to many more openings for clinical research job in Pune and India as a whole.
History and evolution in clinical researchRadhika Nagare
Let's start with the famous quote of Aldous Huxley : "The charm of history and its enigmatic lesson consist in the fact that, from age to age, nothing changes and yet everything is completely different."
Medical research rebuilt_retooled_and_rebootedRadhika Nagare
Medical Research: Rebuilt, Retooled and Rebooted An early stage mobile medical device company developing a human-centered suite of consumer products using science and technology to empower everyday people to monitor and better understand their own health—anytime, anywhere.
Behind the Scenes, Role Of Pharmacists In Clinical ResearchRadhika Nagare
Pharmacists around the world are playing immense roles in the growth of Clinical Research. Some does contribute as a part of their profession and a few are passionate about their behind the scenes role.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
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
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
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
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/
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 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.
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.
2. The prospects of clinical research, especially delivering the
market driven worldwide clinical research trails , including
international bioequivalence studies, started as a pleasant
dream in India in the early 2000s. It was ascertained by many
experts that by 2012, India would be all set emerge as a
global center of excellence for clinical trial.
3. Until the year 2009, it was a pleasant dream and somewhat
smooth in nature, but ever since then there has been a rude
wakening to the fact that since then there has been a
dramatic fall in successfully conducting and delivering the
international CTs outsourced to India. According to some
statistics, this drop is up to about 50% in last 4 years.
4. The apex court further instructed that the government come
up with a new regulatory regime for Clinical trials that would
reflect the concerns of all stakeholders, including subjects
who volunteer to be part of the tests at the risk of adverse
health effects and even death.
5. A lot of work needs to be carried out for worldwide clinical studies
to flow into India again and to grow to the level of the developed
countries. The industry, academia, ethics committees, sponsors
and all other stakeholders are ready to be in pace with the
government.
In the race of many organizations CRB Tech Solutions has a big
name in offering trainings on Clinical Research.
Clinical Research review by CRB Solutions is enough to make you
consider and take up a career in this field.
