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Volunteers publish guide to help public understand fill and finish and drug product release


Article by Staff Writer
VACCINE supplies are currently making headlines for all the wrong reasons as delays in deliveries from drug manufacturers have sparked rising tensions in Europe and increased concerns about “vaccine nationalism”.
While some of the delays are due to manufacturing, others relate to the fill and finish process. In an effort to explain the challenges faced, volunteers from the International Society for Pharmaceutical Engineering UK Affiliate (ISPE UK) and IChemE’s Pharmaceutical Special Interest Group have published the following guide aimed at explaining to the public the process of fill and finish, and drug product release:
The usual form for modern vaccines is a liquid (normally sterile water) containing a number of identical fragments of the organism, protein or RNA strand which the body’s immune system will use to train itself to identify the real organism and build antibodies to fight the infection. This liquid and a few chemical addit ....

United Kingdom , Healthcare Regulatory Authority , Icheme Pharmaceutical Special Interest Group , International Society , Pharmaceutical Special Interest Group , Drug Substance , Quality Control , Quality Assurance , Drug Product , Qualified Person , ஒன்றுபட்டது கிஂக்டம் , சுகாதாரம் ஒழுங்குமுறை அதிகாரம் , சர்வதேச சமூகம் , மருந்து சிறப்பு ஆர்வம் குழு , மருந்து பொருள் , தரம் கட்டுப்பாடு , தரம் உறுதி , மருந்து ப்ராடக்ட் , தகுதி நபர் ,

Why a UK ruling on gender-affirming care for kids could impact youth in the US, threatening access to treatment


Why a UK ruling on gender-affirming care for kids could impact youth in the US, threatening access to treatment
INSIDER
12/22/2020
insider@insider.com (Canela López)
© Provided by INSIDER
Keira Bell, a 23-year-old woman who de-transitioned after taking HRT, sued the NHS for improper guidance. Sam Tobin/PA via AP
The UK s High Court ruled that trans children under the age of 16 are unable to give informed consent to receive medical care such as hormone blockers and hormone replacement therapy. 
The decision comes after Keira Bell, a woman who de-transitioned after she was prescribed hormone replacement therapy, sued the National Health Service (NHS), saying she was not given sufficient guidance.  ....

United States , United Kingdom , Seanj Iwamoto , Sam Tobin , Emma Williams , Hellsite Toolongforatwee , Keira Bell , Endocrine Society , Pediatric Endocrine Society , Medicine Special Interest Group , United Kingdom High Court , National Health Service , Pediatric Endocrine Society Clinical Practice Guideline , Endocrine Society Transgender Research , High Court , Transgender Research , Clinical Practice Guideline , Jeremy Hyam , Family Medicine , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , சாம் டோபின் , எம்மா வில்லியம்ஸ் , கேர மணி , நாளமில்லா சமூகம் , குழந்தை நாளமில்லா சமூகம் ,

Discriminatory policies threaten care for transgender, gender diverse individuals


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WASHINGTON The Endocrine Society and the Pediatric Endocrine Society oppose legislative efforts to block transgender and gender diverse individuals from accessing gender-affirming medical and surgical care, the two medical societies said in a joint policy perspective published in
The Journal of Clinical Endocrinology & Metabolism.
In the past three years, legislators in 17 states have proposed more than two dozen bills barring medical and surgical treatments for transgender and gender diverse youth and adults. Many of these bills reflect widespread misinformation about the nature of evidence-based gender-affirming medical care.
For young children experiencing feelings that their gender does not match the one assigned at birth, known as gender dysphoria, an initial intervention is likely to be a new haircut or clothing, said the manuscript s first author and Co-Chair of the Pediatric Endocrine Society s Transgender Special Interest Group Advocacy Subcomm ....

Rocky Mountain , United States , New York , University Of Texas Southwestern Medical Center , United Kingdom , University Of California San Francisco , San Francisco , Vin Tangpricha , Seanj Iwamoto , Abby Walch , Ximena Lopez , Caroline Davidge Pitts , Endocrine Society , Pediatric Endocrine Society , Medicine Special Interest Group , Emory University School Of Medicine , Endocrine Society Transgender Research , Icahn School Of Medicine At Mount Sinai , Atlanta Va Medical Center , University Of Colorado School Medicine , Mount Sinai Center , Mountain Regional Va Medical Center , High Court , Clinical Endocrinology , California San Francisco , Benioff Children ,

Regulatory policies block transgender and gender diverse individuals from accessing care


Regulatory policies block transgender and gender diverse individuals from accessing care
The Endocrine Society and the Pediatric Endocrine Society oppose legislative efforts to block transgender and gender diverse individuals from accessing gender-affirming medical and surgical care, the two medical societies said in a joint policy perspective published in
The Journal of Clinical Endocrinology & Metabolism.
In the past three years, legislators in 17 states have proposed more than two dozen bills barring medical and surgical treatments for transgender and gender diverse youth and adults. Many of these bills reflect widespread misinformation about the nature of evidence-based gender-affirming medical care.
For young children experiencing feelings that their gender does not match the one assigned at birth, known as gender dysphoria, an initial intervention is likely to be a new haircut or clothing, said the manuscript s first author and Co-Chair of the Pediatric En ....

United States , Rocky Mountain , University Of California San Francisco , United Kingdom , San Francisco , Seanj Iwamoto , Abby Walch , Emily Henderson , Endocrine Society , Pediatric Endocrine Society , Medicine Special Interest Group , Endocrine Society Transgender Research , University Of Colorado School Medicine , Mountain Regional Va Medical Center , High Court , Clinical Endocrinology , California San Francisco , Benioff Children , Senior Author , Transgender Research , Colorado School , Rocky Mountain Regional , ஒன்றுபட்டது மாநிலங்களில் , பாறை மலை , பல்கலைக்கழகம் ஆஃப் கலிஃபோர்னியா சான் பிரான்சிஸ்கோ , ஒன்றுபட்டது கிஂக்டம் ,