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#Phase III #clinical #trials: Is it #better than #what’s #already #available?
#Phase II #Clinical #Trials: #Does The #Treatment #Work?
#Phase I #Clinical #Trials: Is The #Treatment #Safe?
#Drug #Discovery And #Development In #Clinical #Research : A #Molecule's #Journey
#Preclinical #trials: #Sacrificing #animals to #generate #data?
#Basic #concept of #Pharmacology and #pharmaceutical #medicine : #Everything You #Need to #Know
#Basic #Pharmacology And #Physiology Of #Renal #System #Antihypertensive #Drugs
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The uncluttered information is sorted utilizing innovation to get an extensive documentation on ever kind of report.
here to find about cources, training, certification and program about drug safety, pharmacovigilance.
sollers.edu/medical-programs/drug-safety-and-pharmacovigi...
sollers.edu/medical-programs/masters-in-drug-safety-and-p...
Journalist is asking question to two MEPs on Wednesday 22 of September few minutes before the Chamber will vote on the upgrade of medicine safety monitoring to better protect patients.
Patients will be better informed on how to use medicines, and enabled to report their adverse effects directly to national authorities, thanks to updates of EU laws agreed with the Council and endorsed by Parliament on Wednesday. The EU and Member States will set up pharmacovigilance web sites, and medicines that need special monitoring after being placed on the market will be marked with a black symbol.
Read more: www.europarl.europa.eu/news/public/focus_page/008-81949-2...
©European Parliament/Pietro Naj-Oleari
www.reuters.com/business/healthcare-pharmaceuticals/eu-in...
EU investigates reports of menstrual disorders after mRNA COVID shots
Reuters
Feb 11 (Reuters) - The European Medicines Agency's safety committee said on Friday it was reviewing reports of heavy menstrual bleeding and absence of menstruation from women who had received COVID vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE)and Moderna (MRNA.O).
The assessment was in view of reports of menstrual disorders after receiving either of the two vaccines, both based on messenger RNA technology, and it was not yet clear whether there was a causal link, the agency said.
It was not yet clear whether there was a causal link between the vaccines and the reports, the agency said.
Menstrual disorders can occur due to a range of underlying medical conditions as well as from stress and tiredness, the EMA said, adding that cases of such disorders had also been reported following COVID-19 infection.
Vaccination against COVID-19 was linked with a small, temporary change in menstrual cycle length, according to a recent study funded by the National Institutes of Health, which collected data from nearly 4,000 users of a smartphone app that tracks menstrual cycles.
But the EMA said in December it had not established a link between changes in menstrual cycles and COVID-19 vaccines, after a study in Norway suggested some women had heavier periods after being inoculated.
After reviewing the available evidence, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) said it decided to request an evaluation of all available data, including reports from patients and healthcare professionals, clinical trials and the published literature.
The agency on Friday added that there was also no evidence to suggest that COVID-19 vaccines affected fertility.
www.cnbc.com/2022/02/11/covid-no-one-knows-when-the-pande...
Omicron is fading, but nobody knows when the pandemic will finally end
KEY POINTS
The World Health Organization generally defines pandemic as uncontrolled spread of a virus across the globe, and an epidemic is when the spread is limited to a country or region.
A steady level of transmission that doesn't result in a widespread outbreak is generally considered endemic.
Senior U.S. health officials have sought to reassure a pandemic-weary public that the country is moving closer to a time when Covid-19 won't dominate our daily lives, as an unprecedented surge of infections and hospitalizations declines in many parts of the country.
White House chief medical advisor Dr. Anthony Fauci said in an interview this week the U.S. is heading out of the "full-blown pandemic phase" of Covid-19. Fauci has made clear the U.S. won't eradicate Covid, but he's confident the nation can bring the virus under control so it no longer threatens to push hospitals to their breaking point or disrupt the economy. At that moment, people could return to a semblance of normal life after two years of disruption and uncertainty following repeated waves of infection.
"The president has been clear that we're moving toward a time when Covid won't disrupt our daily lives, a time when Covid won't be a constant crisis so we're no longer fearing lockdowns and shutdowns, but getting back to safely doing what we all love," Jeff Zients, the White House's Covid response coordinator, said during a news conference Wednesday.
More mild
Real-world studies from around the globe have demonstrated that the omicron variant, though more contagious, generally doesn't make people as sick as delta. While infections have skyrocketed, hospitalizations and deaths have not risen at the same rate.
Doctors and infectious disease experts in South Africa, in a recent study, said the variant's rapid surge and decline in that country demonstrated a significantly different trajectory than past strains. They say it could be a sign the pandemic will transition into an endemic phase that is less disruptive to society.
"Endemic in general means where you have disease that occurs at a regular and predictable level," said Dr. James Lawler, an infectious disease expert at the University of Nebraska. "There's endemic flu and then there's epidemics of flu every season. Those epidemics generally are predictable and occur within a forecasted range."
There isn't a precise definition of endemic. The World Health Organization generally defines pandemic as uncontrolled spread of a virus across the globe, and an epidemic is when the spread is limited to a country or region. A steady level of transmission that doesn't result in a widespread outbreak is generally considered endemic.
What is endemic
This steady level of transmission is typically reached when the virus's reproductive rate is one or less. That means everyone who gets the virus infects roughly one other person. The original Covid strain had a reproductive rate of about two, while people with delta typically infected five or more other people, according to the Centers for Disease Control and Prevention. Omicron is estimated to be more than three times as contagious as delta, according to a study by Japanese researchers.
The emergence of omicron, with its ability to infect people who are vaccinated and even boosted, has challenged notions of when a sustained endemic phase will come and what it will look like in the context of Covid. Though estimates range, a study by public health authorities in Denmark found that omicron was 2.7 to 3.7 times more transmissible than delta among people fully vaccinated, making it easier for the virus to cause outbreaks even in populations with high immunization rates.
Omicron has also proven adept at reinfecting people, with a recent study in the U.K. finding that two-thirds of people who caught the variant said they had Covid before. This makes herd immunity even more elusive than originally thought. In the first year of the pandemic, government officials hoped of the global vaccination campaign would help eradicate Covid by reaching herd immunity, where enough people have natural or vaccine-induced protection that the virus doesn't have new hosts to infect.
Herd immunity
"The notion of natural herd immunity without vaccination is a scientific untruth," according to Ottar Bjornstad, a professor at Pennsylvania State University who researches disease outbreaks. Though breakthrough infections have become common with omicron, the vaccinated shed less of the virus than people who haven't gotten their shots, he said. Most importantly, the vaccines remain effective at preventing severe disease and death, which is crucial to restoring normal life.
As the effectiveness of the first-two vaccine doses subsides, booster shots have become critical to taming the pandemic. Pfizer and BioNTech's booster shot, for example, is up to 75% effective at preventing symptomatic infection, or illness, according to data from the U.K. Health Security Agency.
"If everybody who was eligible for a third dose got a third dose, and eventually we'll probably need to start giving fourth doses, if we were able to do that we'd be done — pandemic emergency over," Lawler said.
The U.S., however, is nowhere close to that level of booster uptake. Only 64% of the U.S. population is fully vaccinated and just 42% of those people have received a third shot, according to the CDC. And tens of millions of Americans still are not vaccinated at all.
Hope
There is a hope, however, that between vaccination and mass exposure to omicron, there will be enough immunity in the population that the number of people susceptible to falling ill from the virus rapidly diminishes as the latest wave subsides, according to Dr. Kelly Cawcutt, an infectious disease expert at the University of Nebraska.
When Covid first emerged in December 2019, people's immune systems weren't trained to combat the virus, which is why the pandemic has been so devastating. The elderly in particular weren't able to mount an adequate defense, leaving them more susceptible to severe disease and death than other age groups.
As immunity in the broader community increases over time through vaccination and infection, new generations of children will likely become the primary group left that hasn't been exposed, according to Jennie Lavine, a computational investigational biologist at biotech company Karius.
The RBM Procurement and Supply Chain Management working group held a two-day meeting ton 3-4 February 2011. Participants discussed issues around forecasting and quantification, pharmacovigilance, ACT and artemisinin mapping, country bottlenecks, and the use of cell phones to prevent and monitor drug stock-outs.
#British #BioMedicine #Institute #An #Evidence And #Skill #Based #eLearning #Platform
#bbminstitute #bbmclinicaltrials #britishbiomedicine #bjpmr #bjbmr #BBMI #BSCR #BSMD #BBMCT #BBM
#british #Journal Of #Pharmaceutical And #Medical #Research
#British #Journal of #BioMedical #Research
#British #School Of #Clinical #Research
#British #School Of #Medical #Device
#British #BioMedicine #Institute #offers #Skilled #NanoDegree in #Clinical #Trials, #Pharmacovigilance and #Regulatory #Affairs ( #CTPRA)
#Therapeutic #Goods #Administration (#TGA) : An #Australian #Regulatory #Authority
#National #Medical #Products #Administration (#NMPA) : #China #FDA
The Provincial Government of Ilocos Norte, in partnership with a BPO Company based in Manila, kick-off a month-long training on pharmacovigilance and clinical data management for registered nurses. The training started Sept. 1 at the Takuat Training Center and caters to nurses
who want a career in BPO companies with a healthcare background.
(PGIN CMO Photo / Alaric A. Yanos)
The Provincial Government of Ilocos Norte, in partnership with a BPO Company based in Manila, kick-off a month-long training on pharmacovigilance and clinical data management for registered nurses. The training started Sept. 1 at the Takuat Training Center and caters to nurses
who want a career in BPO companies with a healthcare background.
(PGIN CMO Photo / Alaric A. Yanos)
The Provincial Government of Ilocos Norte, in partnership with a BPO Company based in Manila, kick-off a month-long training on pharmacovigilance and clinical data management for registered nurses. The training started Sept. 1 at the Takuat Training Center and caters to nurses
who want a career in BPO companies with a healthcare background.
(PGIN CMO Photo / Alaric A. Yanos)
Event Date 14 – 15 November, Location – Amsterdam, The Netherlands
aureliusglobalmasterclass.com/events/pharmacovigilance-ri...
You get to learn about the role of RWE, AI and other new data sources in this Pharmacovigilance masterclass
You can explore the best practices for implementation of risk minimization measures and their impact in this Pharmacovigilance masterclass.
Pharmacovigilance masterclass is going to take place in Amsterdam. kindly follow the link.
#British #BioMedicine #Institute #An #Evidence And #Skill #Based #eLearning #Platform
#bbminstitute #bbmclinicaltrials #britishbiomedicine #bjpmr #bjbmr #BBMI #BSCR #BSMD #BBMCT #BBM #PHM #CPTRA #CCP #BMAI #MDRA #FST #BSFST #BSCCP #BSAI
#british #Journal Of #Pharmaceutical And #Medical #Research
#British #Journal of #BioMedical #Research #Clinical #Research #Medical #Device
#offers #Skilled #NanoDegree in #Clinical #Trials, #Pharmacovigilance and #Regulatory #Affairs (#CTPRA) #Food #Science #Technology #Clinical #Child #Psychology #Medical #Device #Regulatory #Affairs #Public #Health #Management #Artificial #Intelligence
#Phase III #clinical #trials: Is it #better than #what’s #already #available?
#Phase II #Clinical #Trials: #Does The #Treatment #Work?
#Phase I #Clinical #Trials: Is The #Treatment #Safe?
#Drug #Discovery And #Development In #Clinical #Research : A #Molecule's #Journey
#Preclinical #trials: #Sacrificing #animals to #generate #data?
#Basic #concept of #Pharmacology and #pharmaceutical #medicine : #Everything You #Need to #Know
#Basic #Pharmacology And #Physiology Of #Renal #System #Antihypertensive #Drugs
#Autonomic #Nervous #System (#ANS) #Drugs #Gastrointestinal #Drugs #Respiratory #Disorders #Female #Male #Reproductive #Immune #System #Endocrine #Musculoskeletal #AntiDepressant #AntiParkinson's #AntiSeizure #Agents #Asthma #COPD #Therapy #AntiArrhythmic #AnginaPectoris #Congestive #Heart #Failure
#Hyperlipidemia #Sedative #Hypnotic #Drug #Thyroid #Disorder #Cancer #Chemotherapy #AntiCancer
#British #BioMedicine #Institute #An #Evidence And #Skill #Based #eLearning #Platform
#bbminstitute #bbmclinicaltrials #britishbiomedicine #bjpmr #bjbmr #BBMI #BSCR #BSMD #BBMCT #BBM #PHM #CPTRA #CCP #BMAI #MDRA #FST #BSFST #BSCCP #BSAI
#british #Journal Of #Pharmaceutical And #Medical #Research
#British #Journal of #BioMedical #Research #Clinical #Research #Medical #Device
#offers #Skilled #NanoDegree in #Clinical #Trials, #Pharmacovigilance and #Regulatory #Affairs (#CTPRA) #Food #Science #Technology #Clinical #Child #Psychology #Medical #Device #Regulatory #Affairs #Public #Health #Management #Artificial #Intelligence
#Phase III #clinical #trials: Is it #better than #what’s #already #available?
#Phase II #Clinical #Trials: #Does The #Treatment #Work?
#Phase I #Clinical #Trials: Is The #Treatment #Safe?
#Drug #Discovery And #Development In #Clinical #Research : A #Molecule's #Journey
#Preclinical #trials: #Sacrificing #animals to #generate #data?
#Basic #concept of #Pharmacology and #pharmaceutical #medicine : #Everything You #Need to #Know
#Basic #Pharmacology And #Physiology Of #Renal #System #Antihypertensive #Drugs
#Autonomic #Nervous #System (#ANS) #Drugs #Gastrointestinal #Drugs #Respiratory #Disorders #Female #Male #Reproductive #Immune #System #Endocrine #Musculoskeletal #AntiDepressant #AntiParkinson's #AntiSeizure #Agents #Asthma #COPD #Therapy #AntiArrhythmic #AnginaPectoris #Congestive #Heart #Failure
#Hyperlipidemia #Sedative #Hypnotic #Drug #Thyroid #Disorder #Cancer #Chemotherapy #AntiCancer
ICBio Clinical Research, Clinical Data Management Training Institute in Bangalore, India offers Pharmacovigilance Training, MSc Clinical Research Courses and PG Diploma Courses. Join Today
#British #BioMedicine #Institute #An #Evidence And #Skill #Based #eLearning #Platform
#bbminstitute #bbmclinicaltrials #britishbiomedicine #bjpmr #bjbmr #BBMI #BSCR #BSMD #BBMCT #BBM #PHM #CPTRA #CCP #BMAI #MDRA #FST #BSFST #BSCCP #BSAI
#british #Journal Of #Pharmaceutical And #Medical #Research
#British #Journal of #BioMedical #Research #Clinical #Research #Medical #Device
#offers #Skilled #NanoDegree in #Clinical #Trials, #Pharmacovigilance and #Regulatory #Affairs (#CTPRA) #Food #Science #Technology #Clinical #Child #Psychology #Medical #Device #Regulatory #Affairs #Public #Health #Management #Artificial #Intelligence
#Phase III #clinical #trials: Is it #better than #what’s #already #available?
#Phase II #Clinical #Trials: #Does The #Treatment #Work?
#Phase I #Clinical #Trials: Is The #Treatment #Safe?
#Drug #Discovery And #Development In #Clinical #Research : A #Molecule's #Journey
#Preclinical #trials: #Sacrificing #animals to #generate #data?
#Basic #concept of #Pharmacology and #pharmaceutical #medicine : #Everything You #Need to #Know
#Basic #Pharmacology And #Physiology Of #Renal #System #Antihypertensive #Drugs
#Autonomic #Nervous #System (#ANS) #Drugs #Gastrointestinal #Drugs #Respiratory #Disorders #Female #Male #Reproductive #Immune #System #Endocrine #Musculoskeletal #AntiDepressant #AntiParkinson's #AntiSeizure #Agents #Asthma #COPD #Therapy #AntiArrhythmic #Angina Pectoris #Congestive #Heart #Failure
#Hyperlipidemia