International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Clinical Trial Risk Identification, Management and Reporting from Clinical Development to Marketing; Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, October 12, 2023
European, International organization, Medicine, Thermo Fisher Scientific, Safety, Council, ICF, Legislation, Patient safety, International Council, PPD, Clinical trial, Council for International Organizations of Medical Sciences, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Harmonization, Medical device, Pharmacovigilance, EU

TORONTO, Oct. 12, 2023 /PRNewswire-PRWeb/ -- During this webinar, the featured speakers will bring together the various European Union (EU) and United States (US) pharmacovigilance requirements for risk identification, management and reporting, and examine each component sequentially along the drug development journey.

Key Points: 
  • The featured speakers will discuss the critical interdependencies between signal detection processes, aggregate safety reports, risk management plans, labeling documents and study documents.
  • TORONTO, Oct. 12, 2023 /PRNewswire-PRWeb/ -- During this webinar, the featured speakers will bring together the various European Union (EU) and United States (US) pharmacovigilance requirements for risk identification, management and reporting, and examine each component sequentially along the drug development journey.
  • From a global perspective, foundational to this are the EU and US regulatory requirements applicable to the clinical trial and post-marketing settings.
  • The main elements that will be explored in this webinar include:
    1.

Charles River and PathoQuest Announce Publication of a Head-to-Head Study Validating Proprietary Next Generation Sequencing Viral Safety Assay as a Reliable In Vitro Alternative to Animal Testing Methods

Retrieved on: 
Wednesday, September 6, 2023
Health, Medical Devices, General Health, Research, Science, Pharmaceutical, Biotechnology, Infection, GMP, Harmonization, International Council, NGS, ICH, Doctor of Philosophy, Bioreactor, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Cell, Animal, Guideline, Institut Pasteur de Dalat, CRL, Refinement, DVM, Virus, Pasteur Institute, NYSE, PCR, Vaccine

This unique study demonstrated that PathoQuest’s proprietary, good manufacturing practice (GMP) grade NGS-based assay had a greater capability of detecting viral contaminants when compared to in vivo assays.

Key Points: 
  • This unique study demonstrated that PathoQuest’s proprietary, good manufacturing practice (GMP) grade NGS-based assay had a greater capability of detecting viral contaminants when compared to in vivo assays.
  • The objective of the study was to compare classical in vivo testing methods used to screen cell lines for adventitious viruses with a GMP-compliant viral transcriptome NGS assay.
  • The study was conducted as a head-to-head comparison of standard in vivo testing and NGS-based testing of cell substrates.
  • This project was funded by Charles River and PathoQuest, understanding the importance of the results for future viral safety testing strategies.

NOVOSENSE assists the formulation of LIN transceiver chip standard, promoting the high-quality development of the automotive chip industry

Retrieved on: 
Tuesday, June 13, 2023
Cognition, LIN, Electronics, Intelligence, Research, EMC, Car, OEM, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Instrumentation

Meanwhile, the Standard Drafting Group Meeting on the Technical Requirements and Test Methods for Auto Local Interconnect Network (LIN) Transceiver Chips led by NOVOSENSE was officially held.

Key Points: 
  • Meanwhile, the Standard Drafting Group Meeting on the Technical Requirements and Test Methods for Auto Local Interconnect Network (LIN) Transceiver Chips led by NOVOSENSE was officially held.
  • The representative of NOVOSENSE discussed and communicated with industry experts from more than ten automotive OEM, tier 1 suppliers, and industry organizations on the control mode and function, electrical characteristics, EMC requirements and environmental reliability, LIN communication protocol and consistency testing of LIN transceiver chips.
  • Taking LIN transceiver chip as an example, there are generally about 15-20 LIN transceiver chips on a vehicle, and as many as 30 LIN chips on a vehicle that uses more controllers.
  • With the advancement of the formulation of LIN transceiver chip industry standards, it will further develop the cognition of related chip demand and performance between auto enterprises and chip enterprises, and effectively increase the efficiency and collaboration of the upstream and downstream industry chains.

Relief Therapeutics Announces Swissmedic Approval and Operation of New Good Manufacturing Practice-Compliant Laboratory

Retrieved on: 
Monday, May 15, 2023
GMP, Good manufacturing practice, Relief Therapeutics, International Council, OTCQB, Viscometer, ICH, Research, Australia New Zealand Therapeutic Products Authority, Relief, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Documentation, CGMP, Patient, Agency, Rare, Harmonization, APR, Therapy, HPLC, Fine chemical, Pharmaceutical industry

Swissmedic is the national authorization and supervisory authority for drugs and medical products and devices.

Key Points: 
  • Swissmedic is the national authorization and supervisory authority for drugs and medical products and devices.
  • The next-generation laboratory in Balerna, Switzerland is run by Relief Therapeutics’ subsidiary APR Applied Pharma Research SA (APR) and offers a comprehensive suite of analytical and development services for internal projects and provides external clients with data and full documentation to meet current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and international regulatory authority requirements.
  • “GMP compliance is a critical achievement for our laboratory, enabling us to create, safeguard and supply high-quality products to patients and healthcare providers as well as enable the future submissions of product files to regulatory authorities,” said Paolo Galfetti, chief operating officer of Relief Therapeutics and chief executive officer of APR.
  • “We are excited that our new GMP-compliant lab in Balerna, where innovation is driven by our experienced and highly talented employees, is now Swissmedic-approved and operational,” said Jack Weinstein, chief executive officer of Relief Therapeutics.

Biologics Development and Manufacturing Testing Global Market Report 2023: Increasing Use of Biologics and the Upcoming Introduction of New Products Drives Demand - ResearchAndMarkets.com

Retrieved on: 
Friday, April 28, 2023
Biotechnology, Pharmaceutical, Health, Shenzhen Kangtai Biological Products, Pressure, US Foods, Seed, International Council, European Medicines Agency, ICH, Thermo Fisher Scientific, Biomarker, Solubility, Government, EMA, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Nature, Laboratory, Drug discovery, Quality control, Growth, Merck, R, FDA, Catalent, Safety, Eurofins Scientific, Wuxi, Pharmaceutical industry, Medical device, Fine chemical

Biologics safety testing includes biosafety testing & characterization of raw materials, cell bank & virus seeds, unprocessed bulks/viral harvests, and drug substance/product.

Key Points: 
  • Biologics safety testing includes biosafety testing & characterization of raw materials, cell bank & virus seeds, unprocessed bulks/viral harvests, and drug substance/product.
  • As the biopharmaceutical industry's drug research and development needs continue to increase, this in turn drives enhanced opportunities for the biologics safety testing market.
  • Moreover, increasing government support for the pharmaceutical and biotechnology industries will further boost the demand for biologics safety testing.
  • This is driving the need for advanced biologics testing to accelerate and shorten their development and release to market timelines.

IND-Enabling Nonclinical Studies: How can the Industry Prepare? Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, February 28, 2023
DABT, PMP, Laboratory, IND, Doctor of Philosophy, Attention, GLP, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Toxicology, FDA, Harmonization, International Council, Medical device

TORONTO, Feb. 28, 2023 /PRNewswire-PRWeb/ -- Completing nonclinical studies to support FDA investigational new drug applications is an essential milestone for progressing a new drug into the clinic. Conducting studies according to relevant regulatory requirements, such as good laboratory practices, and guidelines from the FDA and the International Council for Harmonisation is essential for ensuring acceptance by the FDA and that IND-opening clinical trials can proceed without a clinical hold.

Key Points: 
  • In this webinar, learn how to best prepare for conducting and managing IND-enabling nonclinical studies and meeting FDA guidelines.
  • Attendees will gain insights into critical aspects of nonclinical laboratory qualification and obtaining comparable laboratory quotes.
  • For outsourced animal studies, it is tempting to rely solely upon the nonclinical laboratory for study design, conduct, and reporting.
  • Register for this webinar to find out how to best prepare for conducting and managing IND-enabling nonclinical studies and meeting FDA guidelines.

Cervical Cancer Drugs: Industry Trends and Opportunity Forecast, 2026 - ResearchAndMarkets.com

Retrieved on: 
Monday, August 15, 2022
Oncology, AIDS, Health, Consumer, Women, Pharmaceutical, Biotechnology, Woman, Z-100, Risk, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Inflammation, Novartis, Cervical cancer, Bristol Myers Squibb, Diagnosis, Bowen University, Growth, Cancer, Geography, College of Arts and Sciences, Prevalence, Allergan, Eli Lilly and Company, GlaxoSmithKline, Degenerative disease, Pessary, National, COVID-19, Company, Gel, Acquisition, CD4, ICH, Awareness, Human, CAGR, Forecasting, Alnylam Pharmaceuticals, Tablet, HIV, Vagina, Celgene, International Council, Harmonization, Immune system, Disease, Birth control, Pharmaceutical industry, Oil, Retail, Pfizer, Cidofovir

The "Cervical Cancer Drugs Global Market Report 2022, Cancer Type, Drug Type, Distribution Channel" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cervical Cancer Drugs Global Market Report 2022, Cancer Type, Drug Type, Distribution Channel" report has been added to ResearchAndMarkets.com's offering.
  • North America is the largest region in the cervical cancer drugs market in 2021.
  • The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market.
  • The lack of awareness and other misconceptions about cervical cancers hinder the growth of the cervical cancer drugs market.

FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

Retrieved on: 
Thursday, May 19, 2022
Provisions of the Affordable Care Act, Risk, Risk management, Office of Inspector General, U.S. Department of Health and Human Services, Center for Drug Evaluation and Research, Public health, Research, Food, International Council, Cosmetics, Food and Drug Administration Safety and Innovation Act, Patient, Multimedia, Vaccine, China Biologic Products, Human services, Potential, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Innovation Act, FDA, Industry, Center, Lists of disasters, Animal, Dietary supplement, Smokeless tobacco, Congress, Safety, Maintenance, Adoption, Harmonization, Medical device

SILVER SPRING, Md., May 19, 2022 /PRNewswire/ -- Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA's efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.

Key Points: 
  • To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages , intended to help with the development, maintenance and implementation of risk management plans.
  • The steps needed to reduce risks of a disruption in drug supply may vary among the different manufacturers in the supply chain for a given drug.
  • Today's draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply.
  • Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.

Provectus Biopharmaceuticals Announces Synthesis of New Halogenated Xanthene Small Molecule

Retrieved on: 
Thursday, March 24, 2022
Virology, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, CGMP, Company, National, Hematology, Good manufacturing practice, RBS, Forward-looking statement, Immunotherapy, Legislation, ICH, Dermatology, Lead, Ophthalmology, HX, Safety, NIH, Harmonization, International Council, GLOBE, OTCQB, Drug discovery, Microbiology, Pharmaceutical industry, Fine chemical

KNOXVILLE, TN, March 24, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has successfully developed and manufactured a second halogenated xanthene (HX), adding to its lead, clinical-stage, HX small molecule called rose bengal sodium (RBS).

Key Points: 
  • KNOXVILLE, TN, March 24, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has successfully developed and manufactured a second halogenated xanthene (HX), adding to its lead, clinical-stage, HX small molecule called rose bengal sodium (RBS).
  • We are excited to have produced a new halogenated xanthene, further expanding our medical science platform.
  • We look forward to developing this small molecule into a viable Provectus drug product candidate.
  • Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes.

Global Cervical Cancer Drugs Market (2021 to 2030) - Featuring Hetero, GlaxoSmithKline and Allergan Among Others - ResearchAndMarkets.com

Retrieved on: 
Monday, December 20, 2021
General Health, Pharmaceutical, Health, Oncology, Benchmark, Oncology Drug Advisory Committee, Oncology, Cervical cancer, FDA, Z-100, CD4, Awareness, Diagnosis, Gel, ICH, Division, Harmonization, Create, Human, Bowen University, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, National, Safety, Prevalence, Disease, Gynecologic cancer disparities in the United States, Risk, Woman, Tablet, College of Arts and Sciences, Coronavirus, Food, Immune system, HIV, Vagina, International Council, Growth, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pessary, Marketing, Birth control, Cidofovir

The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market.

Key Points: 
  • The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market.
  • The lack of awareness and other misconceptions about cervical cancers hinder the growth of the cervical cancer drugs market.
  • For instance, companies introduced vaginal gels such as Cidofovir gel and 851B Gel into the market to treat cervical cancer.
  • In addition to the above mentioned gels, drugs such as ISA101, AGEN2034 and Z-100 are in pipeline and promise growth to the cervical cancer drugs market.