Drug Patent Watch

DECEMBER 12, 2024

This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics.

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thought leadership

AUGUST 10, 2023

Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices.

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Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Drug Patent Watch

AUGUST 28, 2024

The European Union (EU) has implemented a robust regulatory framework to ensure the quality and safety of active pharmaceutical ingredients (APIs) used in medicines.

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DS in Pharmatics

MARCH 3, 2025

Qualified person (QP) certification and declaration are distinct in their objectives within pharmaceutical and biotech industries. Heres a quick overview: Together, these processes are essential for maintaining EU regulatory compliance, []

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ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

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Government Compliance Pharmaceutical Companies Pharmaceuticals 52

H1 Blog

NOVEMBER 15, 2023

Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

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Compliance Science Regulations Pharmaceutical Companies 59

FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.

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thought leadership

APRIL 10, 2025

Explore key steps to successfully enter the European pharmaceutical market, including navigating regulatory frameworks, ensuring quality compliance, and obtaining Wholesale Distribution Authorization.

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Marketing Pharmaceuticals Compliance Science 52

thought leadership

SEPTEMBER 19, 2024

Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes us through the highs and lows of ensuring her company meets the rigorous FDA CAPA (Corrective and Preventive Actions) requirements.

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market.

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thought leadership

SEPTEMBER 2, 2024

Navigate the complexities of EU GMP compliance with ProPharma’s expert guidance. Learn essential strategies for ensuring quality and safety in pharmaceutical manufacturing.

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thought leadership

MARCH 12, 2025

When a pharmaceutical company completes clinical trials and prepares to launch a medical product, the focus often shifts to regulatory approvals, market access, and commercialization.

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Advarra

DECEMBER 14, 2023

This enables higher levels of training compliance over the course of study conduct, as well as the necessary understanding of trial activities to perform the right task at the right time. In addition, providing CROs and sponsors visibility to site training compliance allows them to provide additional support and mitigate risk if necessary.

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Compliance FDA Clinical Trials Trials 52

DS in Pharmatics

JANUARY 16, 2024

The pharmaceutical industry is growing through global collaboration and market expansion. To continue this growth, regulatory compliance for Chemistry, Manufacturing and Controls (CMC) must be followed. Without CMC regulatory compliance, the safety behind the creation of any products could be compromised.

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Drug Channels

APRIL 19, 2021

Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.

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DS in Pharmatics

JUNE 12, 2024

Date: June 12, 2024 Location: San Diego, CA ProductLife Group (PLG), a leading provider of product development and compliance services in the pharmaceutical and biotechnological sectors, is excited to announce a comprehensive solution aimed at transforming the landscape of drug development, underscoring PLG's commitment to advancing healthcare through (..)

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Production Pharmaceuticals Compliance Drug Development 52

Drug Patent Watch

JANUARY 9, 2025

The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation. Managing Quality and Compliance Quality and regulatory compliance are non-negotiable in pharmaceutical manufacturing. How can you ensure your CDMO is up to scratch?

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The Premier Consulting Blog

NOVEMBER 6, 2024

Improved convenience and patient compliance: ICPs can offer improved convenience for patients by requiring only one device, rather than two or more separate inhalers – ultimately resulting in better patient compliance. However, these products present unique challenges from a Chemistry, Manufacturing, and Controls (CMC) standpoint.

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Production FDA Compliance Disease 52

Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.

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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.

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Pharmaceuticals Compliance Regulations Production 52

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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thought leadership

SEPTEMBER 9, 2024

On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following documentation.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico.

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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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Clinical Trials Regulations Compliance Government 98

Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. The post Regulatory Considerations for Pharmaceutical Product Lifecycle Management appeared first on Advarra.

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Drug Channels

SEPTEMBER 18, 2023

Showcasing high level discussions on access strategy, patient interactions, case management, compliance practices and more, this two-and-a-half-day event helps navigate complex compliance hurdles to advance and enhance your patient-oriented programs. And so many more! Comprehensive Content and Dynamic Features Include : 2.5

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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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 Pharmaceuticals Regulations 59

thought leadership

APRIL 4, 2025

Pharmaceutical tariffs of 25% have been forecasted causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio. The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy.

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Pharmaceuticals Regulations Government Production 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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Fierce BioTech

JULY 15, 2024

This webinar explores the regulatory landscape, emphasizing compliance strategies for industries producing pharmaceuticals, medical devices, and related products. Click here to login. Listing Image Alcami_ListingLogo_250x190.png On Demand Start Date Thu, 09/12/2024 - 11:00

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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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Alta Sciences

NOVEMBER 4, 2024

Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs aasimakopoulos Mon, 11/04/2024 - 17:37 Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing.

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Engineering Production Compliance Laboratories 52

Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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Drug Channels

JULY 11, 2022

President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S. O’Brien, Pharm.

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Fierce BioTech

MAY 7, 2024

Trust Transformed: Pharma Marketing in the Post-Cookie Era dwunderlin Tue, 05/07/2024 - 13:29 Tue, 06/11/2024 - 14:00 Resource Type Webinar David Minkin Clifton Covey Sonia V Gupta Duration 60 Minutes In the backdrop of digital advertising for pharmaceuticals we are undergoing a radical transformation as privacy becomes a paramount concern.

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