Omnicell

JANUARY 10, 2023

In just four years, an impressive 21 states have passed or modified state laws preventing pharmacy benefit managers (PBMs) and other commercial payers from reimbursing 340B providers at a lower rate than other pharmacies. Supreme Court decision that ruled that states can regulate PBM behavior.

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Pharmaceutical Technology

MARCH 10, 2023

Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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Documentation Packaging Vaccines 59

The Checkup by Singlecare

DECEMBER 26, 2023

For many patients with diabetes, particularly those with Type 1 diabetes, insulin is a key part of managing glucose levels and preventing complications. However, many patients may have trouble getting the insulin they need, whether due to high costs or limited options. What are insulin biosimilars?

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pharmaphorum

JANUARY 17, 2022

As the only parallel trade conference in Europe, this event provides the perfect platform for industry experts from both sides of the coin to come together and share perspectives on the practice of parallel trade. Shabnam Hanassab, Engagement Manager, iQvia. Hynek Valerián, Group Parallel Trade Manager, Dr.Max group.

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Packaging Vaccines 52

PQA

DECEMBER 1, 2023

CPESN affiliated speakers demystified the change management process by outlining 4 critical steps and emphasizing the crucial part pharmacy staff play in achieving success. In support of this goal, PQA has performed a review of its bylaws and proposes revisions which modernize and streamline this important governing document.

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Community Pharmacies Documentation Communication 59

Board Vitals - Pharmacist

AUGUST 31, 2022

A survey conducted by a neurology practice in Arizona found that 15% fewer parents are allowing their children to play football, lowering the total to 59%. According to the CDC , all 50 states and the District of Columbia have now passed “return-to-play” laws. High School Football Numbers Dropping. And it gets worse.

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pharmaphorum

AUGUST 25, 2020

For over 60 years the ABPI Code of Practice has been key to the UK industry’s self-regulation, and now, as pharma is experiencing its most intense period of change in decades, a new update seeks to bring the Code in line with the modern sector. How well do you think industry self-regulation works at the moment?

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The FDA Law Blog

SEPTEMBER 28, 2023

Walsh — As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. And the risk is the same regardless if the “person” is a corporation or a natural person, a mid-level manager or a CEO.

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European Pharmaceutical Review

DECEMBER 21, 2022

Likewise, in December 2022, Health Canada outlined its expectations that clinical trial sponsors will include in their protocols the best-practice risk-management measures they intend to implement in their psychedelic-assisted psychotherapy studies. For many indications, progress has been incremental.

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Compounding Controlled Substances FDA Patient Care 114

Board Vitals - Pharmacist

JANUARY 9, 2021

As new regulations are implemented to combat the ongoing opioid crisis, more state medical licensing boards are requiring pain management and safe opioid prescribing-related CME as part of their annual continuing education requirements. What are My State’s Pain Management and Opioid CME Credit Hour Requirements ? (As

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Controlled Substances 52

The FDA Law Blog

NOVEMBER 30, 2022

Brevig, Senior Regulatory Device and Biologics Expert — Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” By JP Ellison & Holly N.

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ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

DiversifyRx

NOVEMBER 24, 2023

pharmaceutical industry is wrapped up in a web of regulations, and one of the most significant in recent years is the Drug Supply Chain Security Act (DSCSA). To achieve this, the U.S. For pharmacy owners, it’s not just a legal requirement; it’s a required step in ensuring the safety of the drug supply chain. Its main goals are: 1.

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Independent Pharmacies Packaging Documentation FDA 52

ISPE

MARCH 7, 2023

Supporting standards for science-based targets are available and being refined to help organizations measure and manage their environmental impact. This article explores effective management and oversight processes for accelerated delivery of large-scale programs of work. 1 United Nations.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

BuzzRx

OCTOBER 14, 2022

Note: Making copies of commercially available medications is not allowed by law. There are 56,000 community pharmacies in the US. Only around 7,500 are compounding pharmacies, of which only 3,000 perform sterile compounding. Please continue reading to find out more about human drug compounding and compounded medications.

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ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. The resulting complexity requires manufacturers to tightly control and manage supply chain activities for commercial products globally to maintain compliance.

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Documentation FDA Communication Packaging 52

The FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. An important part of the 2022 Guideline includes CDC’s pronouncement that some laws, regulations and policies have misapplied the 2016 guidelines and likely contributed to patient harm. By Larry K. MMWR Recomm Rep 2022;71(No. RR-3):1–95.

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ISPE

JULY 10, 2023

ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Trudy Patterson Mon, 07/10/2023 - 15:37 Technical July / August 2023 ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Martin Heitmann, FRM Stefan MÜNCH Brandi M. That said, is this technology also helpful in regulated areas of pharma?

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

FEBRUARY 7, 2023

Changes have been spurred by the COVID-19 pandemic, which emphasised the need to urgently modernise outdated EU pharmaceutical law and revise regulatory ambitions in the MedTech sector. It is hoped that the regulation will contribute to harmonisation of the regulatory framework governing conduct of clinical trials throughout the EU.

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Packaging 101

PharmaShots

MARCH 9, 2023

Shots: Trailblazing, inspiring, and emancipating, women’s contribution to society is highly significant. We are esteemed and elated to present a list of the 20 women who have excelled in reaching the summit of excellence, arranged alphabetically Total experience: 16 yrs. Present company and time period: Pfizer (2 yrs.)

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European Pharmaceutical Review

JULY 20, 2023

On 14 July 2022, the European Commission published a proposal for a regulation on substances of human origin (SoHO) intended for human application. 1 The proposed regulation is currently in the legislative process and intended to replace the largely-outdated legislation on Blood, Tissue and Cells (BTC legislation).

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Labelling Documentation Hospitals 69

Board Vitals - Pharmacist

JANUARY 6, 2023

For license renewals, at least 2 of the total hours of CME that are required to qualify for renewal must be specific to pain management and opioid use and addiction. Arkansas The Arkansas State Medical Board requires 20 hours of CME annually with 50% of the AMA PRA Category 1 Credits targeting the main area of practice.

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Controlled Substances Documentation 59

ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. Continuous reactions and processes are a fundamental concept taught to all undergraduate chemical engineers, often in their junior year.

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FDA Dosage Documentation Pharmaceutical Companies 52

Pharmaceutical Technology

OCTOBER 25, 2022

The multiple platforms and apps used in professional and personal lives present significant challenges for data management systems. Otherwise, theoretically, they could be in breach of regulations.”. Furthermore, data regulations around the world add another burden of compliance and need careful management.

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HIPAA Pharmaceutical Companies Pharmaceutical Companies Medical Records 52

ISPE

MARCH 15, 2023

Whitford Emily Heffernan, PE Aoife Kelly 1 March 2023 Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. 7 An integrative (vs.

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Packaging Labelling Health Compliance Process Improvement 52

The Thyroid Pharmacist

APRIL 28, 2023

In my own practice, many of my clients have had some form of muscle complaint, often involving muscle loss, muscle weakness, pain, and/or cramps. I had so many frustrating symptoms, including anxiety, irritable bowel syndrome (IBS) and acid reflux. I’ve shared articles on pain and will be sharing one on carpal tunnel soon as well.)

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The Thyroid Pharmacist

JULY 21, 2022

My thyroid condition was missed completely, leading me to deal with needless “mystery” symptoms like chronic fatigue, depression, anxiety, and many others, for far too long! I still have a copy of my lab results from 2008, before I was diagnosed with Hashimoto’s. According to this lab report, my TSH was at 4.5 ? Perhaps a TSH of 4.5 ?IU/mL

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Dosage Insurance Immunization 75

pharmaphorum

FEBRUARY 1, 2022

The MHRA has kicked off an eight-week consultation on proposals for changes to laws governing the conduct of clinical trials following the UK’s departure from the EU. Get involved today and help shape future legislation: [link] #ResearchSavesLives pic.twitter.com/X0g7VX8xLH. — MHRAgovuk (@MHRAgovuk) January 21, 2022.

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Documentation 52

European Pharmaceutical Review

JULY 1, 2022

With the advent of social movements such as #MeToo and Black Lives Matter, and the impact of the COVID-19 pandemic, the priorities and concerns of employers are shifting significantly. The broad landscape. ESG is an umbrella term for the tools used to measure the sustainability and ethical impact of a business.

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Pharmaceutical Companies Pharmaceutical Companies Documentation 92

pharmaphorum

OCTOBER 3, 2022

Now, in Part II, the authors look more closely at the practical affordability of implementation outside of the United States, weighing up the possibilities offered within Asia, Africa, and South America, as well as the power Europe and the UK yield in any potential outcome.]. Lands of opportunity: Asia, Africa, and South America.

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Chemotherapy Pharmaceutical Companies Pharmaceutical Companies FDA 98

European Pharmaceutical Review

JULY 25, 2022

Criminals were able to capitalise on supply chain disruptions, industry regulations being in transition and the urgent global demand for medical products; consequently they thrived. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. trillion 3 worldwide.

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Packaging 90

Pharmaceutical Technology

NOVEMBER 1, 2022

The medicines regulators in Europe have a strategy for 2025 where the second pillar is data and digitalisation, so we are trying to transform medicines regulation to be data-driven,” says Peter Arlett, Head of Data Analytics and Methods Task Force at EMA. Arlett explains that Darwin EU is playing a collaborative role in this goal.

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pharmaphorum

SEPTEMBER 1, 2020

Switzerland’s total lack of patent laws led to it being accused of being a “pirate state” in the German Reichstag. The 21st century pharmaceutical and biotech sector has come a long way from its roots in 19th century pharmacy. pharmaphorum looks at its evolution over the centuries.

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pharmaphorum

JANUARY 12, 2021

2021 will reveal just how the ILPA will be operationalised and whichever product will be the first to go through the Innovation Passport stage – a new designation as part of ILAP – will help everyone understand how the criteria for the passport will apply in practice. The promise of faster market access . The Netflix approach.

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Documentation 81

The Thyroid Pharmacist

DECEMBER 7, 2022

We are exposed to many chemicals each day, both inside and outside our homes. Those of us with Hashimoto’s often have difficulty removing these toxins from our bodies — a factor that can trigger and worsen an autoimmune condition. This is why we need to be especially diligent when it comes to addressing chemical exposure in our day-to-day lives.

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Health and Personal Care Stores Labelling Immunization Compounding 54

The Thyroid Pharmacist

JULY 29, 2022

As I searched for my own root causes, I found that many people with thyroid conditions can have multiple sensitivities to environmental toxins. Breathing in pollutants is inflammatory, and triggers an immune response as the body tries to process out the toxins. It was weeks before we even left our windows open again.

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Health and Personal Care Stores Compounding Immunization Labelling 52

The Thyroid Pharmacist

JUNE 14, 2023

I have some very special men in my life as well — my hubby Michael, my son Dimitry, my dad, my brother, my father-in-law, and some dear friends… Happy sixth Father’s Day, Michael!) This article is dedicated to all of the special men in your life. (I You may have seen this article last year, around this time — some things have changed!

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