Risk management plan

Challenges in Assessing Long-Term Effects of Covid and Covid Vaccines, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, March 8, 2023
Risk management plan, Data, Aggregate, Vaccine, Pregnancy, ICON, Risk management, Inflammation, Autoimmunity, SARS-CoV-2, Patient safety, Big data, Patient, Literature, Collection, Clinician, Immunodeficiency, Safety, Senior, Observation, Coronavirus, Pharmaceutical industry, COVID-19, Pharmacovigilance

TORONTO, March 8, 2023 /PRNewswire-PRWeb/ -- Since December 2019, when the SARS-CoV-2 novel coronavirus was first reported in Wuhan, China, the pandemic has infected more than 750 million people and claimed more than 6.8 million lives. Subsequent vaccine discovery and implementation has allowed us to move forward out of the pandemic — over 13 billion vaccine doses have been administered to date. However, the exceptionally fast pace of development of the vaccines, and the accelerated approval process meant the long-term effects of covid vaccines remained inconclusive.

Key Points: 
  • In this free webinar, learn about the Clinicians perspective and insight of Covid cases, long Covid, challenges with sharing their observation and their understanding of the need for this information.
  • Attendees will learn about Big Data — the challenges and solutions in collection and assessment of the vast volume of data associated with Covid.
  • The featured speakers will discuss regulatory expectation for Market Authorization Holders (MAHs) for post-authorization safety surveillance of Covid vaccines.
  • Join the featured speakers as they explore the challenges in assessing the long-term effects of Covid and Covid vaccines and how ICON's advanced data analysis techniques can manage large amounts of safety data.

REDUVO™ Marketing Approval on the Right Path

Retrieved on: 
Thursday, December 22, 2022
Tetra, Patient, Vomiting, Plasma protein binding, NDS, Health Canada, Weight loss, TSX, Insurance, TBP, Dronabinol, FRA, FDA, THC, Inflammation, Safety, Risk management plan, Risk management, HIV/AIDS, News, HIV, Multimedia, Cannabis, CINV, Pain, Nausea, Legislation, Physician, Research, Pharmaceutical industry

The Company will be submitting the response to Health Canada within the allowed timeframe.

Key Points: 
  • The Company will be submitting the response to Health Canada within the allowed timeframe.
  • Questions/feedback from Health Canada are received as the review of the dossier progresses through different review streams.
  • It is also used to treat weight loss and severe nausea in people living with HIV infection.
  • The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.

TMC Subsidiary NORI Commences Monitoring of the Environmental Impacts of Pilot Nodule Collection System Trials in the Clarion-Clipperton Zone

Retrieved on: 
Wednesday, October 5, 2022
Environmental issues, U.S. Securities and Exchange Commission, Vale, Sequoia, Shell, SEC, BGR, Review, Clipperton Fracture Zone, Rio Tinto, Scripps, Regulation, EIS, Sumitomo Group, Private Securities Litigation Reform Act, TMC, Challenger, Research, International Seabed Authority, Collection, Partnership, Technology, Biodiversity, NEW, American Metal Company, Allseas, INCO, Company, Kennicott, Environmental monitoring, Mineral, CCZ, MIT, Risk management plan, U.S. Steel, ISA, Environment, GLOBE, Forward-looking statement, The Hidden Gem, HMS, Kingdom, GSR, COVID-19, Ownership, BP, Mining, Risk management, Copper, Rare-earth element, Pacific Ocean

The Companys Environmental Program Manager, Dr Michael Clarke, said: Testing of a fully integrated nodule collection system is a landmark event in the progression of our nascent industry.

Key Points: 
  • The Companys Environmental Program Manager, Dr Michael Clarke, said: Testing of a fully integrated nodule collection system is a landmark event in the progression of our nascent industry.
  • Having established a baseline of the NORI-D collector test area, scientists will proceed to monitor the environmental impacts of deployment and testing of the fully integrated nodule collection system.
  • Last month NORI announced that it received the ISAs recommendation to commence its pilot nodule collection system trials in the CCZ after its review of the Environmental Impact Statement (EIS) and Environmental Monitoring and Management Plan (EMMP).
  • Trials of prototype nodule collectors have been successfully conducted by several ISA contractors including BGR and GSR in the recent years.

Galapagos receives positive CHMP opinion for Jyseleca® European label update based on testicular function safety data from MANTA/RAy studies

Retrieved on: 
Monday, October 3, 2022
Ministry of Health, Labour and Welfare, Committee for Medicinal Products for Human Use, Gilead Sciences, Interview, Risk management plan, Man, Product, Type, Week, Galapagos NV, MANTA, IBD, EMA, UC, Committee, NASDAQ, RA, Ankylosing spondylitis, Disease-modifying antirheumatic drug, Patient, CET, European Medicines Agency, Inflammatory bowel disease, Inflammation, RC, Adult, Physician, Reproduction, D, Fertility, Advanced Accelerator Applications, Twitter, Fibrosis, Ulcerative colitis, Medication package insert, Semen, JAK1, Tablet, Rheumatoid arthritis, LinkedIn, RMP, Disease, CHMP, Male, CD, Safety, Union, Euronext, Language, Contraindication, Pharmaceutical industry, Birth control, Medical imaging, Galápagos Islands, Filgotinib, European, Health

We will now work to update all relevant label information and materials with the aim to increase access to Jyseleca so that European patients who may benefit from the treatment are able to receive it.

Key Points: 
  • We will now work to update all relevant label information and materials with the aim to increase access to Jyseleca so that European patients who may benefit from the treatment are able to receive it.
  • Further, CHMP concluded that the data did not show any relevant changes in sex hormone levels or change from baseline in semen parameters across treatment groups.
  • Overall, CHMP concluded that these clinical data were not suggestive of filgotinib-related effects on testicular function.
  • Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan.

The Metals Company Subsidiary, NORI, Receives ISA Recommendation to Commence Pilot Nodule Collection Trials in the Clarion Clipperton Zone of the Pacific Ocean

Retrieved on: 
Wednesday, September 7, 2022
Biodiversity, Kennicott, COVID-19, CEO, Technology, Environmental monitoring, Research, Radio Technical Commission for Aeronautics, EIS, Rio Tinto, International Seabed Authority, GSR, Environmental issues, Clipperton Fracture Zone, Republic, ISA, CCZ, The Hidden Gem, Kingdom, Ownership, Collection, Environmental impact statement, Private Securities Litigation Reform Act, American Metal Company, TMC, Forward-looking statement, SEC, BGR, Review, Risk management plan, U.S. Securities and Exchange Commission, NEW, GLOBE, Pacific Ocean, Company, Mineral, Regulation, Feedback, Shell, Sumitomo Group, Copper, Rare-earth element, Atlantic Ocean, Allseas

Upcoming integrated nodule collection system trials will mark the first such trials to be conducted in the CCZ since the 1970s.

Key Points: 
  • Upcoming integrated nodule collection system trials will mark the first such trials to be conducted in the CCZ since the 1970s.
  • The conclusion of the International Seabed Authoritys review process allows NORI to proceed with its planned integrated pilot collection system trials in its NORI-D exploration contract area in the Clarion Clipperton Zone (CCZ) of the Pacific Ocean.
  • Based upon this feedback and with over 600 comments received, an updated EIS was submitted to the ISA in March 2022.
  • TMC cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made.

Update: Chlorine Institute Recognizes 35 North American and International Facilities For "Diamond Level" Safety and Environmental Performance

Retrieved on: 
Monday, April 4, 2022
Diamond, Zero, Chlorine, Sodium, Dow Chemical Company, Â, Vinyl chloride, CI, RMP, Packager, SK, Sodium hypochlorite, Oshkosh, VCM, Injury, Occidental Petroleum, Safety, GLOBE, Risk management plan

CIs safety and environmental recognition program highlights the industrys ongoing commitment to safety performance and continuous improvement, said CI President Frank Reiner.

Key Points: 
  • CIs safety and environmental recognition program highlights the industrys ongoing commitment to safety performance and continuous improvement, said CI President Frank Reiner.
  • Diamond Level facilities not only aimed for zero, they achieved it, and their performance serves as benchmarks for the entire industry.
  • The recognition is based on 2021 safety and environmental data, and a complete list of the recipients is below.
  • By recognizing facilities that successfully Aim for Zero, CI encourages all facilities to set the highest bar for safety and environmental performance, while promoting continuous improvement.

Chlorine Institute Recognizes 15 North American and International Facilities For “Diamond Level” Safety and Environmental Performance

Retrieved on: 
Thursday, March 31, 2022
Diamond, Zero, Chlorine, Sodium, Dow Chemical Company, Â, Vinyl chloride, CI, RMP, Packager, SK, Sodium hypochlorite, Oshkosh, VCM, Injury, Occidental Petroleum, Safety, GLOBE, Risk management plan, OH, Bottled water, Speciality chemicals

CIs safety and environmental recognition program highlights the industrys ongoing commitment to safety performance and continuous improvement, said CI President Frank Reiner.

Key Points: 
  • CIs safety and environmental recognition program highlights the industrys ongoing commitment to safety performance and continuous improvement, said CI President Frank Reiner.
  • Diamond Level facilities not only aimed for zero, they achieved it, and their performance serves as benchmarks for the entire industry.
  • Diamond Level recognition is the Triple Crown for safety and environmental excellence, Mr. Reiner said.
  • By recognizing facilities that successfully Aim for Zero, CI encourages all facilities to set the highest bar for safety and environmental performance, while promoting continuous improvement.

Luye Pharma Group Selects LifeSphere® Signal and Risk Management to Automate Drug Safety Signal Detection

Retrieved on: 
Thursday, April 23, 2020
Financial law, Quantitative analyst, Valuation, Financial risk, Risk management plan, Articles, Economy, Management

ArisGlobal's LifeSphere Signal and Risk Management will assist Luye Pharma to embrace advanced qualitative and quantitative in-depth signal detection and to streamline their risk management planning across their global locations.

Key Points: 
  • ArisGlobal's LifeSphere Signal and Risk Management will assist Luye Pharma to embrace advanced qualitative and quantitative in-depth signal detection and to streamline their risk management planning across their global locations.
  • LifeSphere Signal and Risk Management will enable Luye Pharmato automate signal management across its drug development portfolio, thus improving operational efficiency.
  • "We're excited to have LuyePharma leveraging LifeSphere Signal and Risk Management to implement effective signal detection strategies across their product portfolio," said Sankesh Abbhi, President and CEO of ArisGlobal.
  • LifeSphere Signal and Risk Management helps organizations to proactively identify and manage safety issues and easily assess their impact on a product's benefit-risk profile across its life cycle.

Luye Pharma Group Selects LifeSphere® Signal and Risk Management to Automate Drug Safety Signal Detection

Retrieved on: 
Thursday, April 23, 2020
Financial law, Quantitative analyst, Valuation, Financial risk, Risk management plan, Articles, Economy, Management

ArisGlobal's LifeSphere Signal and Risk Management will assist Luye Pharma to embrace advanced qualitative and quantitative in-depth signal detection and to streamline their risk management planning across their global locations.

Key Points: 
  • ArisGlobal's LifeSphere Signal and Risk Management will assist Luye Pharma to embrace advanced qualitative and quantitative in-depth signal detection and to streamline their risk management planning across their global locations.
  • LifeSphere Signal and Risk Management will enable Luye Pharmato automate signal management across its drug development portfolio, thus improving operational efficiency.
  • "We're excited to have LuyePharma leveraging LifeSphere Signal and Risk Management to implement effective signal detection strategies across their product portfolio," said Sankesh Abbhi, President and CEO of ArisGlobal.
  • LifeSphere Signal and Risk Management helps organizations to proactively identify and manage safety issues and easily assess their impact on a product's benefit-risk profile across its life cycle.