ALiEM - Pharm Pearls

MARCH 29, 2023

Children 29 days or older with fever from a documented viral source can be managed according to their clinical presentation and can go outside the algorithm. This requires a documented positive viral swab and not just a presentation consistent with a viral syndrome. 2020 Dec 17:hpeds.2020-0187. Epub 2020 Oct 31.

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

Pharma Pathway

FEBRUARY 14, 2023

Walk-In Drive for B.Sc / M.Sc/ B.Pharm/ B.Com/ B.A/ ITI/ Diploma Freshers in Quality Control/ Production/ Warehouse On 16th Feb’ 2023 @ Granules India Limited Department: Quality Control/ Production/ Warehouse Experience: Freshers Qualification: B.Sc / M.Sc/ B.Pharm/ B.Com/ B.A/

Pharmaceutical Manufacturing 87

Pharmaceutical Manufacturing Documentation 87

Pharma Pathway

JANUARY 6, 2023

Passed out year: 2019 -2020. Kindly Carry the below Documents with you: . Walk-In Interviews for Freshers On 7th Jan’ 2023 @ Granules India Limited (Gagillapur-Hyderabad). Qualification: Intermediate (M.P.C/ Age: 18 -20 years. Percentage: passed Candidates with Consistent academic record of min 55% in 10th & Intermediate.

Pharmaceutical Manufacturing 81

Pharmaceutical Manufacturing Documentation 81

Pharma in Brief

APRIL 26, 2021

As previously reported in June 2020 ( June 2020 Update ), the FCA began to gradually lift the indefinite Suspension Period, [1] by adding ongoing files to its Selected Files List. By the fall of 2020, the Suspension Period had been lifted on all pending FCA files. Selected Files. Hearings will continue to be heard remotely.

Documentation 52

Documentation 52

RX Note

NOVEMBER 19, 2023

There is also a chapter of nutritional support in Critical Care Pharmacy Handbook, 2020. NOTE: In 2018, a revision of guidelines on paediatric parenteral nutrition is published by the ESPEN, ESPGHAN, ESPR together with the CSPEN to provide up-to-date evidence. ASPEN published new guidelines for parenteral nutrition in preterm infants in 2023.

Hospitals 52

Hospitals Documentation Compounding 52

Pharmaceutical Technology

APRIL 6, 2023

Accord US BioPharma president Chrys Kokino said: “The promise of HLX02’s reference product — Herceptin1 — is well documented, and we’re thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology and critical care.

Biosimilars 52

Biosimilars Documentation 52

Express Pharma

SEPTEMBER 18, 2023

In 2020, the company launched The Only Progress is Human to increase awareness of societal and environmental challenges and inspire the use of virtual worlds to drive sustainable innovations in areas such as urbanisation and water conservation.

Documentation 92

Documentation Communication Vaccines 92

Pharma Pathway

FEBRUARY 14, 2023

Age: 18 -20 years Passed out year: 2020 -2022 Percentage: passed Candidates with Consistent academic record of min 55% in 10th & Intermediate Location: Hyderabad Date: 16th Feb’ 2023 Time: 9:00 AM to 12:00 PM Venue: Granules India Limited, Sy.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Documentation 52

Pharma in Brief

JUNE 23, 2020

On June 11, 2020 the Federal Court ( FC ) and Federal Court of Appeal ( FCA ) published updated notices to gradually phase out the Suspension Period, which had previously been extended to June 15, 2020. The 14-day buffer at the end of the Suspension Period for the filing of documents and other procedural steps ends on July 13, 2020.

Documentation 40

Documentation 40

Pharma in Brief

JANUARY 12, 2023

In the redetermination, the Minister did not review certain correspondence between the Office of Submissions and Intellectual Property ( OSIP ), Médunik, and the TPD from April to July 2020 (the Additional Documents ).

Documentation 52

Documentation 52

pharmaphorum

MARCH 16, 2021

In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. The documentation was not complete and the leaks did not show how the agency’s concerns were satisfied, the BMJ added.

Vaccines 137

Vaccines Documentation 137

pharmaphorum

JANUARY 13, 2021

The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

Vaccines 72

Vaccines Documentation 72

Drug Channels

SEPTEMBER 3, 2020

This week, I’m rerunning some popular posts while I work on the forthcoming 2020-21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post and comments from June 2020. You’ll find the document links below. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc.

Documentation 52

Documentation 52

Pharma Pathway

MARCH 2, 2023

Quality Control – 1 to 5 years experience BA/ B.Com/ B.Sc Freshers for Warehouse department. ITI/ Diploma/ B.Sc Freshers for OSD Production department.

Pharmaceutical Manufacturing 81

Pharmaceutical Manufacturing Documentation 81

RX Note

APRIL 21, 2023

Insert Page Number To start inserting page number, you can either double click header or footer section of the document, a new tab of "Header & Footer". You may tick on " Different First Page" if the document includes cover page. Save As the document and give a File Name Change the type to PDF Click the " Options."

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements.

Controlled Substances 116

Controlled Substances Documentation 116

pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines.

Pharmaceutical Companies 94

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 94

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting. Feature image copyright BioNTech SE 2020, all rights reserved.

Vaccines 101

Vaccines Documentation 101

Pharma Pathway

MARCH 14, 2023

Passed out year: 2020 to 2022 Age: 18 -22 years Percentage: 60% & above in all Academics. Job Location: Hyderabad/Secunderabad( Gagillapur ) Date: 17th March 2023 Time: 10:00 AM to 01:00 PM Venue: Granules India Limited, Sy.

Pharmaceutical Manufacturing 40

Pharmaceutical Manufacturing Documentation 40

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 72

Adverse Reactions Documentation Medical Schools Packaging 72

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. In addition, the median time between regulatory approval and the first patient receiving a first dose was 247 days in 2020 – an increase of 25 days since 2018.

Documentation 98

Documentation 98

Pharma in Brief

JUNE 2, 2020

The Federal Court of Appeal ( FCA ) and the Federal Court ( FC ) have extended their Suspension Periods to June 15, 2020. On May 28, 2020, the FCA issued a Notice to the Parties and the Profession extending the Suspension Period to June 15, 2020. in-person hearings will not be held until July 13, 2020. Federal Court.

Documentation 40

Documentation 40

Drug Channels

JULY 21, 2020

Last week, I documented that nearly half of U.S. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. pharmacies now participate in the 340B Drug Pricing Program. Below, we update our exclusive analysis of the biggest specialty pharmacies within 340B. d/b/a Drug Channels Institute.

Specialty Pharmacies 52

Specialty Pharmacies Drug Pricing Documentation Hospitals 52

pharmaphorum

NOVEMBER 20, 2020

Based on current projections the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document.

Vaccines 95

Vaccines Documentation 95

Pharma in Brief

JULY 1, 2020

On June 25, 2020, the Federal Court ( FC ) issued its latest Practice Direction and Order ( FC Update ) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC still encourages parties to file documents electronically.

Documentation 40

Documentation 40

pharmaphorum

NOVEMBER 1, 2021

The document says that Sleepio shows promise as a treatment for insomnia in primary care that could be an alternative medicines and sleep hygiene advice, but it is uncertain whether it will be cost-saving for the NHS. The consultation document is open for comment until 29 November, with final recommendations schooled by 12 May next year.

Documentation 58

Documentation 58

RX Note

JUNE 4, 2023

For all suppliers, a document (e.g. External Links Guideline on Good Distribution Practice, 2018 Garis Panduan Pengurusan Farmasi Logistik, 2020 These guidelines help prevent the introduction of substandard or falsified products into the market. Disposal records should be maintained for a defined period.

Documentation 40

Documentation Labelling 40

European Pharmaceutical Review

AUGUST 1, 2022

The HMA/EMA Big Data Steering Group, set up in May 2020 to advises both the EMA and HMA on the implementation of ten priority recommendations highlighted by the Big Data Task Force, reviews its workplan annually to cover any new emerging topics.

Documentation 88

Documentation 88

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 82

Documentation Pharmaceutical Companies Pharmaceutical Companies 82

Eye on FDA

AUGUST 10, 2023

The second spike occurred in 2020, coinciding with the COVID-19 pandemic. While the FDA in Brief documents covered only one topic, the FDA Roundup can cover several and includes an update on COVID-related activities, meaning that while the overall volume of releases is down, the overall volume of information may, in fact, be up.

Communication 80

Communication Documentation 80

Pharma in Brief

OCTOBER 29, 2020

On October 22, 2020, the Federal Court ( FC ) issued new Case and Trial Management Guidelines for Complex Proceedings (the FC Guidelines ). Trial management conference: Timing and mode of delivery of trial documents are to be discussed during the trial management conference.

Documentation 52

Documentation 52

Drug Channels

MAY 19, 2020

You’ll find the document links below. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. COVID-19 has not stopped the wheels of policy bureaucracy from grinding. Last week, the Centers for Medicare and Medicaid Services (CMS) released its final Notice of Benefit and Payment Parameters for the 2021 benefit year.

Documentation 52

Documentation 52

Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

Documentation 52

Documentation Compounding Pharmaceutical Manufacturing 52

pharmaphorum

FEBRUARY 8, 2022

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US. .”

Documentation 52

Documentation Chemotherapy 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab). According to documents in the PTO’s Patent Center, Lilly has not yet filed a response.

Documentation 59

Documentation 59

pharmaphorum

FEBRUARY 10, 2021

The project is coordinated by the University of Bologna and funded by the European Union’s Horizon 2020 research and innovation programme that involves more than a dozen partner institutions, including Italian startup InSilicoTrials.

Drug Development 67

Drug Development Packaging Documentation Hospitals 67

ID Stewardship

OCTOBER 28, 2022

Since the news of virtual Midyear in 2020, many residency programs have created social media accounts, most often on the platform Twitter. Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts.

Documentation 91

Documentation 91