Pharma in Brief

JANUARY 24, 2021

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2020. The year saw the first trials and decisions in actions under the new Patented Medicines (Notice of Compliance) Regulations ( PM(NOC) Regulations ). Introduction. Major Policy Initiatives. (a) a) COVID-19.

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PharmaState Academy

MARCH 4, 2024

Your words carry the weight of authority and experience, instilling confidence in your team while also setting a high bar for performance. With a clear plan of action in place and a shared sense of purpose, they leave the meeting feeling empowered and inspired to make the most of the opportunities that await.

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Communication 52

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. Meanwhile, the Ontario Superior Court released two decisions dismissing claims made by a generic manufacturer under the Ontario and English Statutes of Monopolies , and common law causes of actions. a) COVID-19.

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Quality Matters

MAY 23, 2023

Members of the APEC panel on the topic discussed illegal online pharmacies as a “whole of Internet problem” with nearly overwhelming size and scale. What can we do? The collaborative, multi-year project was led by regulators and representatives from industry, academia, non-governmental organizations, and international groups.

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Online Pharmacies Controlled Substances Packaging Communication 52

Express Pharma

DECEMBER 11, 2023

He also highlighted the importance of building health infrastructure, skill development, regulatory compliance, diversifying product portfolios to mitigate risks, and promoting training and awareness programmes. He accentuated that this approach is crucial to maintain trust and credibility among stakeholders.

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Packaging Communication Documentation 102

PharmaShots

APRIL 17, 2023

Therapeutic treatment may include systemics, both oral or injectable, phototherapy or topicals, but despite a variety of available treatments, many patients remain undertreated or untreated. What is unique about its mechanism of action (MOA)? Daniel Quirk: In September, the U.S.

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Quality Matters

OCTOBER 13, 2021

There are also related standards that address a wide range of topics such as packaging, storage and distribution of medicines, the preparation of compounded medicines and prescription labeling. Reducing Drug Shortages The COVID-19 pandemic brought a greater focus on the problem of drug shortages in the U.S.

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Pharmaceutical Manufacturing Adverse Reactions Prescription Filling Compounding 52

pharmaphorum

AUGUST 17, 2020

The financial world, like the pharmaceutical industry, must operate within a tightly-defined regulatory environment, and in doing so has proved adept at connecting with its customers. Utilising 3D animation, motion graphics, illustration and data visualisation, Mechanism of Action videos are created to visually explain drug or device impact.

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The Happy PharmD

AUGUST 4, 2023

I’m used to stating what action needs to be taken and then having others listen and follow my choices. But as I drifted out of the management realm, other people assumed the authority to make the calls. One of the topics on our agenda was seeking new members for our committee. I didn’t always agree with their decisions.

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PharmaShots

MARCH 6, 2023

Put simply, AI is when computers and other machines mimic human cognition, and are capable of learning, thinking, and making decisions or taking actions. In addition, the user can extract the eligibility criteria and other relevant clinical, safety, and regulatory information. Clinical trials are a key topic for these interactions.

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Eye on FDA

MARCH 10, 2021

First we will look at a change in how FDA is reporting regulatory actions by OPDP on the FDA website, and second we will cover the most recent such action. For reasons indiscernible to this author, the agency recently split Warning Letters from Untitled Letters and now displays them in separate parts of the FDA site.

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Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 72

Viseven

JUNE 15, 2023

Leverage capturing, reporting, and actioning medical insights. Over 1,400 attendees got an opportunity to learn the hottest trends in omnichannel engagement, global-to-local marketing, automation, data analytics, medical legal regulatory (MLR) review, and many other topics.

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Communication 52

GMPSOP

MARCH 30, 2024

Regulatory guidelines for line clearance US FDA CFR 211, Sec. As the process is carried out, the line opening form must be completed and signed by two authorized persons counter-checking each other’s work. After an operation, an authorized person must perform the line cleaning using an approved line cleaning form.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

MARCH 4, 2023

I will try my best to provide an outline of this topic which I have learned over the past few years. Quality management system is concerned with ensuring that pharmaceutical products consistently meet regulatory requirements and customer expectations. Would the failure lead to a product recall or other regulatory action?

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Documentation Communication Method Validation Packaging 52

PharmaShots

APRIL 26, 2023

mL Mechanism of Action: interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor First Approvals: FDA (Mar 28, 2017), EC (Sep 27, 2017), NMPA (Jun 19, 2020), MHLW (Jan 22, 2018) Originator: Sanofi & Regeneron Revenue Analysis1 Dupixent is developed and commercialized in collaboration with Regeneron. Topical Rxs didn't help.

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Eye on FDA

FEBRUARY 1, 2023

One aspect largely missed in the media reporting on the PHE conclusion is in regard to whether or not the action has an impact on the Emergency Use Authorization (EUA) status conferred by FDA on a number of vaccines, diagnostic tests, and medicines during the COVID emergency. Impact on EUAs?

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Vaccines Communication Hospitals 84

European Pharmaceutical Review

JULY 1, 2022

Diversity and inclusion – pharmaceutical companies may be required to comply with certain legal requirements relating to topics such as inclusion and non-discrimination. Those organisations which demonstrate good ESG policies now will be far better placed to comply with future regulatory developments and avoid penalties.

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Pharmaceutical Companies Pharmaceutical Companies Documentation 86

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). By Charles G. Raver & James E. Valentine & Frank J.

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Viseven

JULY 12, 2022

If you regularly google the equivalent topics to become a medical content ninja, you’re in the right place. Generate leads by inviting professionals and non-experts to online events to discuss various topics and trends. Become an Authority with an SEO-Friendly Blog. Write on multiple topics. Be patient. Support.

Communication 52

Communication Documentation Hospitals 52

The Thyroid Pharmacist

JULY 8, 2022

Selenium’s job of neutralizing the hydrogen peroxide produced during thyroid hormone conversion (via the actions of glutathione peroxidase), becomes even more critical when a person has high iodine levels. The build-up of reactive oxygen species in cells can cause damage to DNA or even cell death.

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Dosage Immunity Immunization Diabetes 59

Pharmaceutical Technology

JUNE 22, 2023

The EU previously focused on AMR through the One Health Action Plan, which was released in 2017. Beyond this, AMR was also the topic of talks in the European Parliament during a recent plenary session on 1 June. Baraldi was one of the authors of The Lancet article alongside Årdal.

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Drug Development Documentation Communication 52