Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials. There is now growing pressure for regulators to take action.

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Fierce BioTech

JULY 15, 2024

Nitrosamines in Focus: Regulatory Requirements and Best Practices dwunderlin Mon, 07/15/2024 - 11:10 Thu, 09/12/2024 - 10:00 Resource Type Webinar Chris Williams Chad Bastian Duration 60 Minutes Nitrosamines, potent carcinogens, have prompted stringent regulations for their detection and control in various products. Click here to login.

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Compliance Laboratories Pharmaceuticals Regulations 52

DS in Pharmatics

JULY 7, 2023

As a supply chain expert in the biotech and pharmaceutical industry, I understand the unique challenges faced by companies operating in this highly regulated and complex sector.

Pharmaceuticals 52

Pharmaceuticals Compliance Regulations Production 52

Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Production Compliance Pharmaceuticals 40

FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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Compliance FDA FDA Approval Drugs 52

thought leadership

MAY 3, 2024

In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. Particularly, within the European Union (EU) and the United Kingdom (UK), QP audits play a pivotal role in maintaining compliance with stringent regulatory standards.

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Compliance Regulations Pharmaceuticals Production 52

Drug Channels

SEPTEMBER 16, 2024

The Patient Support Services Congress is designed to help educate and share innovative program design, latest customer strategies and practical solutions to overcome complex access barriers, enhance program performance and deliver best-in-class patient programs amidst evolving regulations.

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Compliance Regulations Pharmaceuticals Drugs 52

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Clinical Trials Production International 40

thought leadership

MAY 8, 2024

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking registration and market access in the European Union (EU) for their products.

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Pharmaceutical Companies Compliance Regulations Pharmaceuticals 59

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Production Biosimilars Clinical Trials 40

thought leadership

OCTOBER 23, 2023

In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices , and other regulatory requirements is paramount.

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Compliance Regulations Pharmaceuticals 52

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Pharmaceuticals Production Packaging 40

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. Fiona Maini, Senior Director Global Compliance and Strategy at Medidata “AI is dominating conversations across the drug discovery process.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh will contribute her extensive expertise in FDA regulatory matters to a session titled “Global Ad Promo and Enforcement Insights,” addressing the complex landscape of advertising and promotion compliance on a global scale. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms.

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Compliance FDA Regulations Government 59

FDA Law Blog: Drug Discovery

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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FDA Compliance Pharmaceuticals Pharmaceutical Companies 59

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. a synthetic control arm)?

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Fierce BioTech

APRIL 11, 2024

Benefits: Gain insights into GMP compliance, understand critical considerations for storage optimization, and learn about Alcami's unique capabilities. png Listing Introduction Discover the critical factors driving GMP compliance with five crucial considerations for pharmaceutical storage. Click here to login.

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Compliance Pharmaceuticals Regulations FDA 52

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Research Compliance Clinical Trials 52

DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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Compliance Regulations Clinical Trials Government 74

Fierce BioTech

JANUARY 19, 2024

Uncover the revolutionary role of video in transforming communication within the pharmaceutical industry and learn how to harness its power effectively. Join us to understand the impact of social video, from engaging healthcare professionals, patients, and caregivers to crafting a winning strategy that aligns with compliance standards.

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Compliance Pharmaceutical Companies Pharmaceuticals Regulations 52

Perficient: Drug Development

AUGUST 20, 2024

Industry-specific Attributes: Chemicals, electronics, pharmaceuticals, etc. Compliance and Regulatory Adherence: Certain industries require strict compliance with regulatory standards. Usage: Consumables, repairable items, capital goods, etc.

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Compliance Production Pharmaceutical Companies Pharmaceuticals 52

Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. Rising costs : The rising costs of clinical trials, including expenses associated with recruiting participants, trial infrastructure, data management, and regulatory compliance, is a critical issue4,5.

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Pharma Companies Clinical Trials Compliance Trials 52

ACTO

SEPTEMBER 26, 2023

Understanding the ROI Challenge in Pharma Training Before delving into the potential of personalized learning, it's crucial to understand pharmaceutical companies' challenges when measuring training ROI. Conclusion The pharmaceutical industry is complex, and sales representatives must stay ahead of the curve.

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Compliance Pharmaceuticals Pharmaceutical Companies Engineering 52

ACTO

APRIL 28, 2023

The pharmaceutical industry is facing a critical challenge of unapproved content usage in the field, as revealed in a recent survey conducted by Citeline, that explored the prevalence and impact of this behavior. “Compliance starts with the sales force understanding its importance. Stay updated on regulations.

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Compliance Regulations Pharmaceuticals Production 52

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms.

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Compliance FDA Government International 59

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Palmer , Larry K. Houck , and Kalie E.

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Licensing Licensing Pharmacy Regulations 45

The Premier Consulting Blog

MAY 4, 2023

Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

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FDA Packaging Compliance Regulations 52

Drug Target Review

AUGUST 9, 2024

Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 3 Patient compliance is a critical but complex challenge, with contributing factors reaching beyond just drug formulation. What is drug formulation?

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Science Drugs Compliance Drug Development 59

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. PPD ® Laboratory services are backed by a proven track record with over three decades of experience providing CMC pharmaceutical testing.

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Laboratories Assay Development Small Molecule Packaging 52

The Pharma Data

JANUARY 6, 2021

Discover five good manufacturing practices for water monitoring and sanitization for pharmaceutical use. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark. Download Your Copy.

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Compliance Regulations Production Pharmaceuticals 52

The Pharma Data

JANUARY 13, 2021

Avoid risking the quality of water in manufacturing practice, subsequent product process delays and compliance issues with this handy guidebook. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark.

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Compliance Regulations Production Pharmaceuticals 52

Drug Discovery World

MAY 17, 2024

The need to protect this data isn’t just about compliance with laws like HIPAA or GDPR; it’s about maintaining trust. There are more – regulations, validations and integrations. Without robust privacy measures, we risk not only ethical breaches but also the very foundation of patient trust that clinical trials depend on.

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The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. Moreau, CEO of Algernon Pharmaceuticals. About Algernon Pharmaceuticals Inc. . Moreau CEO Algernon Pharmaceuticals Inc. VANCOUVER, British Columbia, Dec. This is another important step for the Company,” said Christopher J. Christopher J.

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Pharmaceuticals Regulations Compliance Licensing 52

Drug Channels

SEPTEMBER 13, 2021

Thought-leaders and colleagues from federal agencies, bio/pharma manufacturers, consultants, industry trade associations and law firms will gather to discuss key insights on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices.

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Compliance Drugs Regulations Science 75

FDA Law Blog: Biosimilars

MARCH 24, 2024

Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation. Code Ann. § McClain , No.

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Pharmacy Regulations Compliance Government 59

Drug Discovery World

MAY 15, 2024

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. million diagnosed cases of diabetic retinopathy in the nine major pharmaceutical markets, expected to grow to >17.7 Beech has over 25 years of biotech and pharmaceutical industry experience.

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