Clinical Research and Regulation - Clinical Research Informer

PCI frames new regulations based on amendments under Jan Vishwas Act

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.

Regulation

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Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

AUGUST 29, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Regulation

National Commission for Homoeopathy notifies BHMS regulations

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 13, 2022

The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Homoeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy).

Regulation

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CDSCO empowers regulators & boosts exports through comprehensive training programmes

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as […]

Regulation

Regulation Drugs Clinical Trials Clinical Trials

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

Clinical Research

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Keeping Up with the Clinical Research Compliance Landscape

ACRP blog

FEBRUARY 11, 2025

If theres one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, its change. The Academy agenda covers: Human research protections U.S. Learn more about HCCA The post Keeping Up with the Clinical Research Compliance Landscape appeared first on ACRP.

Compliance

Compliance Clinical Research Research Regulation

Advancing and Safeguarding Clinical Research for a Better Tomorrow

Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

Clinical Research

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Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 24, 2023

An MoU […]

Regulation

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CE Act should be adopted on priority basis to effectively regulate path labs in the country: Dr. Arvind Lal

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2023

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities.

Regulation

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MHRA revamps UK clinical trial regulation with the promise of faster timelines

Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

Clinical Trials

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Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

JANUARY 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021.

Clinical Research

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15 Clinical Research Job Roles & Responsibilities (2021)

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

Clinical Research

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Clinical Research Jobs: How to Choose the Right Career Path

XTalks

FEBRUARY 22, 2021

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella.

Clinical Research

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UK ATMP clinical research picture remains positive despite challenging global environment

BioPharma Reporter

JANUARY 17, 2023

In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.

Clinical Research

Clinical Research Research Trials Regulation

Back to School for Graduate Studies in Clinical Research: A Snapshot of U.S. Programs

ACRP blog

SEPTEMBER 12, 2024

ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. Some are recent undergraduates and others mid-career professionals or clinicians.

Clinical Research

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2025: Perspectives and Predictions From Advarra Thought Leaders

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

Clinical Research

Clinical Research Research Trials Clinical Trials

Five states yet to report formation of Appropriate Authority under ART, Surrogacy Regulation Acts

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 18, 2022

With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority.

Regulation

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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

Clinical Research

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Clinical Research Technology Comparison: Telemedicine Versus Video Conferencing for Healthcare

VirTrial

AUGUST 21, 2021

A telemedicine platform intended for clinical trials must provide broader functionalities to accommodate the various needs of sponsors, CROs, patients, clinicians, investigators, research site staff, and regulators, as well as meet international regulatory requirements. This post originally appeared on Signant Health.

Clinical Research

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Propelling clinical research into the 21st century

pharmaphorum

NOVEMBER 15, 2022

A renaissance in vaccines research is just one example of something good to come out of the pandemic. For the clinical trials industry, the pandemic forced new ways of working and fresh ways of thinking about clinical research and how to conduct it remotely.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Building Inclusive Science: The Vital Role of Diversity, Equity and Inclusion in Clinical Research

XTalks

SEPTEMBER 9, 2024

Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinical research.

Clinical Research

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

NOVEMBER 10, 2024

FY2024 Awardees & Observations For the FY2024 Orphan Products Clinical Trials Grants Program, FDA received 51 grant applications and awarded only seven new clinical trials a grant, providing more than $17.2 million to clinical researchers over the next four years to advance the development of medical products for rare diseases.

Production

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How to Weather the Clinical Research Talent Recruitment Storm

ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. “It The post How to Weather the Clinical Research Talent Recruitment Storm appeared first on ACRP.

Clinical Research

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Pharma Pulse 8/28/24: AI Regulation Is Coming, A Case for Payer Engagement/Participation in Clinical Research & more

Pharmaceutical Commerce

AUGUST 28, 2024

The latest news for pharma industry insiders.

Clinical Research

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Fierce Biotech Article: Paul Evans on Clinical Trials in 2025

Velocity Clinical Research

DECEMBER 30, 2024

A new Fierce Biotech article features insights from Paul Evans on what to expect for clinical research in 2025. Topics include rising costs and uncertain regulations, as well as the continued emergence of site networks, AI-driven efficiency (with technology built by trial sites, for trial sites), and enhanced diversity initiatives.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Parental permission, child assent, and adolescent autonomy in clinical research

pharmaphorum

MAY 28, 2024

Navigating the ethical landscape of clinical research with minors: exploring the HHS and FDA regulations around parental permission, child assent, and adolescent autonomy under CFR 46. Learn how to ethically and legally involve young participants in studies.

Clinical Research

Clinical Research Research Regulation

This Protein May Protect Against Alzheimer’s, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2023

In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.

Protein

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Eating Late Can Change How You Burn Calories And Store Fat, Depressing Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 7, 2024

A study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat. link] With obesity now affecting hundreds of millions of people worldwide, this is a valuable insight into how […]

Regulation

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SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

Clinical Trials

Clinical Trials Clinical Trials Drugs Regulation

NMC amends rules for setting up medical institutes

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 26, 2022

The National Medical Commission (NMC), the apex medical education regulatory body, has come out with draft Establishment of Medical College Regulations, (Amendment), 2022 ushering changes in rules for setting up medical institutes. According to […].

Regulation

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Advanced Clinical to host event looking at increasing clinical research talent at DIA 2023

Outsourcing Pharma

JUNE 14, 2023

In a bid to address the high demand for clinical research talent, Advanced Clinical is hosting an innovation theater at DIA Global in Bostonâs Convention and Exhibition Center.

Clinical Research

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DCA Telangana raids & seizes illegally made cough syrups in Hyderabad

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 19, 2024

Click here Policy & Regulations + Font Resize – DCA Telangana raids & seizes illegally made cough syrups in Hyderabad Peethaambaran […] Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.

Regulation

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SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

All the medical devices including in-vitro diagnostic medical devices have come under the regulation […]

In-Vitro

In-Vitro Licensing Licensing Regulation

SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

Vaccine

Vaccine Vaccination Clinical Trials Clinical Trials

DGFT amends export obligation period for imports of drugs from unregistered sources towards ease of doing business

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 12, 2024

In a significant move to enhance trade facilitation and streamline compliance with foreign trade regulations, the Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has announced amendments to the export obligation period for several import items.

Compliance

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CDSCO declares 59 drugs tested in August as Not of Standard Quality

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 3, 2024

The State drug regulators have reported 11 NSQs to the CDSCO […] The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test.

Drugs

Drugs Regulation Manufacturing Clinical Trials

Move to relax clinical trial norms will cut Indian pharma’s human studies cost, lower drug prices for patients

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

Clinical Trials

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EU regulators issue guidance on decentralised trials

pharmaphorum

DECEMBER 19, 2022

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) group – launched earlier this year – intended to further develop the EU’s role as a centre for clinical research.

Regulation

Regulation Trials Clinical Trials Clinical Trials

The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach. How regulators will interpret and enforce its provisions may not become clear for some time.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Industry awaits positive govt response on draft notification on OTC drugs

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2023

The pharmaceutical industry in the country is waiting for the positive government response on the suggestions on the draft notification about the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945 and laid down specific provisions for its regulation in the country.

Drugs

Drugs Regulation Clinical Trials Clinical Trials

SEC recommends approval for HLL Lifecare’s graphene condom

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the (..)

Regulation

Regulation Manufacturing Production Marketing

Centre notifies Rules for CCSEA with provisions for deemed approval & grading of animal house facilities

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 12, 2023

The Central government has notified the administrative Rules for the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory Committee to regulate and monitor experiments on animals to prevent cruelty to animals, with provisions for deemed approval and grading of animal house facilities in medical colleges, pharmacy colleges, (..)

Pharmacy

Pharmacy Regulation Vaccine Vaccination

PCI frames new regulations based on amendments under Jan Vishwas Act

Psychedelic clinical trials: What sponsors should know when designing new protocols

Trending Sources

National Commission for Homoeopathy notifies BHMS regulations

CDSCO empowers regulators & boosts exports through comprehensive training programmes

The New Age of Decentralized Clinical Trials

The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP

Keeping Up with the Clinical Research Compliance Landscape

Advancing and Safeguarding Clinical Research for a Better Tomorrow

Cabinet approves signing of MoUs between India and Suriname in the field of medical products regulation

CE Act should be adopted on priority basis to effectively regulate path labs in the country: Dr. Arvind Lal

MHRA revamps UK clinical trial regulation with the promise of faster timelines

Clinical research in 2021: A new era of collaboration and innovation

15 Clinical Research Job Roles & Responsibilities (2021)

Clinical Research Jobs: How to Choose the Right Career Path

UK ATMP clinical research picture remains positive despite challenging global environment

Back to School for Graduate Studies in Clinical Research: A Snapshot of U.S. Programs

2025: Perspectives and Predictions From Advarra Thought Leaders

Five states yet to report formation of Appropriate Authority under ART, Surrogacy Regulation Acts

Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Clinical Research Technology Comparison: Telemedicine Versus Video Conferencing for Healthcare

Propelling clinical research into the 21st century

Building Inclusive Science: The Vital Role of Diversity, Equity and Inclusion in Clinical Research

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

How to Weather the Clinical Research Talent Recruitment Storm

Pharma Pulse 8/28/24: AI Regulation Is Coming, A Case for Payer Engagement/Participation in Clinical Research & more

Fierce Biotech Article: Paul Evans on Clinical Trials in 2025

Parental permission, child assent, and adolescent autonomy in clinical research

This Protein May Protect Against Alzheimer’s, Scientists Say

Eating Late Can Change How You Burn Calories And Store Fat, Depressing Study Shows

SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

NMC amends rules for setting up medical institutes

Advanced Clinical to host event looking at increasing clinical research talent at DIA 2023

DCA Telangana raids & seizes illegally made cough syrups in Hyderabad

SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children

DGFT amends export obligation period for imports of drugs from unregistered sources towards ease of doing business

CDSCO declares 59 drugs tested in August as Not of Standard Quality

Move to relax clinical trial norms will cut Indian pharma’s human studies cost, lower drug prices for patients

EU regulators issue guidance on decentralised trials

The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

Industry awaits positive govt response on draft notification on OTC drugs

SEC recommends approval for HLL Lifecare’s graphene condom

Centre notifies Rules for CCSEA with provisions for deemed approval & grading of animal house facilities

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