PharmExec

DECEMBER 20, 2023

This podcast addresses critical topics such as cybersecurity, regulatory compliance and fiscal strategy for pharmaceutical labs and offers valuable insights for professionals at the crossroads of technology, finance, and pharmaceutical regulations.

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The FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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ISPE

JUNE 2, 2023

It involves a wide variety of analytical technologies, requires well trained analysts, and is a major component of the critical path to regulatory submissions and product release. Given the inherent importance of QC to the pharmaceutical industry, ISPE is excited to introduce the newly launched QC/Analytical Community of Practice (CoP).

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European Pharmaceutical Review

OCTOBER 13, 2022

The first focus will be to improve how work related to COVID-19 is handled: interactions with regulators, prioritising topics, managing medicines with no marketing authorisation, planning for HTAs and economic modelling methods. The bodies will work collectively on scientific and methodological topics to address these difficulties.

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Communication 88

European Pharmaceutical Review

AUGUST 3, 2022

The ideas and proposals put forward on this topic during the recent EDQM Symposium on Nanomedicines will be taken into account during the process, as will the experience gained with these vaccines during the COVID-19 pandemic, in which mRNA vaccines garnered regulatory approval for the first time.

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Vaccines 97

ISPE

AUGUST 15, 2023

This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ Maria Amaya, Lead External Advocacy North America (Quality Policy) at Genentech, and Jean-François Duliere, Regulatory Advisor at ISPE, are honoured to co-chair Track 1 Annex 1, ATMPs and Pharma 4.0™: ™ QbD Regulatory

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PQA

JULY 10, 2023

Health information technology and public policy are two topics in health care that are continually evolving, as is their impact on medication use quality. and Kroger Health, presents a session on Navigating the Quality Regulatory Environment. Four additional courses are available now in the PQA Education Center.

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The FDA Law Blog

NOVEMBER 30, 2023

The speaker faculty of top FDA regulatory authorities will share critical insights on foreign and domestics inspections, digital health, DOJ’s compliance guidelines, and data privacy, among many other topics. The conference will also include its annual panel discussion with FDA’s Center Compliance Directors.

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ISPE

APRIL 13, 2023

Primary benefits include acceleration of the steps for design, scale-up, and regulatory approval for all process unit operations, in support of bringing new drugs to market in a timely manner. iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry.

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European Pharmaceutical Review

NOVEMBER 17, 2023

Lebrikizumab represents a “significant step forward” in patients with moderate-to-severe atopic dermatitis not controlled with topical therapy due to its selective mechanism of action, proven short and long-term efficacy and safety and a monthly maintenance dosing for all patients. EC approval was based on three pivotal Phase III studies.

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Hospitals 87

ISPE

JUNE 23, 2023

Yet another important topic is understanding the CMC levers to accelerate the speed to market expectations and strategies to ensure quality therapeutic products are brought to market in an efficient manner. We have included some key topics in this session which will prove beneficial to all attendees.

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PharmaShots

JUNE 23, 2023

Shots: Cassiopea will receive an up front & is also eligible to receive regulatory and sales milestones along with royalties on net sales Hyundai Pharm to get an exclusive right to register and commercialize Winlevi in the Republic of Korea while Cosmo will be the exclusive supplier of the product.

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The FDA Law Blog

MARCH 6, 2023

The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. Keen observers may have noticed that in the most recent semiannual regulatory agenda , neither the Quality System Regulation nor the Quality Management System Regulation is referenced.

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ISPE

APRIL 28, 2023

When Speed to Market Counts Trudy Patterson Fri, 04/28/2023 - 12:19 iSpeak Blog iSpeak When Speed to Market Counts David Doleski Laura-Ann Shaa Ling Chin, BSc, MSc, PE 28 April 2023 Speed to market is a major priority for life sciences companies and this is going to be a featured topic during the 2023 ISPE Biotechnology Conference.

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Pharmaceutical Technology

MAY 24, 2023

Streamlining the regulatory process, the AMP BGTC will also facilitate cost-efficient vector production to increase access for patients with rare and ultra-rare genetic diseases. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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FDA 96

The FDA Law Blog

MARCH 15, 2023

Topics will include FDA and USDA regulatory compliance and enforcement, inspections, recalls, food safety technology, and emerging and growing product categories such as cell-cultured meat and Cannabis ingredient-infused products.

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OctariusRx

JULY 20, 2023

If you need guidance on this topic or would like us to help you enhance patient safety and regulatory compliance, contact us for a free initial consultation. Do you know what steps to take in case of a suspected diversion? In this week’s newsletter to our clients, we address these questions and more.

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Controlled Substances 61

Pharma Mirror

SEPTEMBER 4, 2020

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry.

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The FDA Law Blog

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M. Truly, these are complex considerations.

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Pharmaceutical Technology

JUNE 9, 2023

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

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Pharmaceutical Technology

DECEMBER 5, 2022

According to the deal, Incyte is entitled to receive an upfront payment from CMS, which will also make further potential payments on meeting development, regulatory and commercial milestones. Ruxolitinib cream is the first topical inhibitor of JAK to obtain approval in the US.

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The FDA Law Blog

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. Walsh brings to the table an unparalleled depth of FDA regulatory expertise.

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ISPE

NOVEMBER 23, 2022

The Symposium program comprised a wide range of presentations and panel discussions on GMP-related topics, which included participation from Heads of Medicines Agencies, Heads of GMP Inspectorates, official PIC/S representatives and ISPE. And it is important that our regulatory responsibilities allow innovation to thrive.

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ISPE

FEBRUARY 14, 2023

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC) and managed by ISPE regulatory staff.

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European Pharmaceutical Review

AUGUST 1, 2022

According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. In addition, searching for information from regulatory documents will be enhanced through the development of analytics tools and the development of standardised clinical trial protocols.

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Documentation 96

OctariusRx

DECEMBER 27, 2022

Unbelievably, we are quickly approaching 2023 and it’s time to look back at of the biggest topics of 2022. Below is a summary of the top topics that generated the most questions and interest in 2022. Use our tool to help enhance patient safety and satisfy the regulatory requirement. How much does compliance cost?

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OctariusRx

MARCH 11, 2024

Good medication management also makes regulatory compliance easier. Your pharmacy consultant should be an expert on this topic and help guide your processes to ensure everyone is protected. If your systems are not quite up to regulatory standards, let us help you.

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IDStewardship

MAY 12, 2023

As residents review the topics they need to cover during their residency, it can be helpful to also include the Board of Pharmacy Specialties examination content outline for the specialty area in addition to ASHP requirements. Within each pharmacy specialty there will be numerous niche topics for learners to familiarize themselves with.

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European Pharmaceutical Review

MAY 2, 2023

Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

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ISPE

MAY 2, 2023

These submissions show even more collaboration happening, not only with each other, but with regulatory agencies on a global scale. They provide unique, multi-faceted experiences on the topics, with emphasis on real-world tested solutions. Building on the success of 2022, the conference speakers come from all corners of the globe.

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European Pharmaceutical Review

JUNE 26, 2023

The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. RWE shows efficacy of nirsevimab for infant RSV The post How can real-world evidence support regulatory decision making? appeared first on European Pharmaceutical Review.

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pharmaphorum

OCTOBER 12, 2022

Understand the latest regulatory requirements from regulatory experts surrounding medical devices and digital health. Steve Hoare, Quality, Regulatory Science & Safety Policy Director, The Association of the British Pharmaceutical Industry (ABPI). Blake Green, Director Regulatory Affairs, Amgen.

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Packaging 52

Pharmaceutical Technology

APRIL 27, 2023

Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections. Notably, this includes the reduction of regulatory data protection from eight years to six— a decision which will likely prove controversial.

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Fuld

NOVEMBER 29, 2022

Used a customized schedule of monthly topics to report on a quarterly basis to give the client flexibility based on the dynamics of the market. ?. Our Solution. Fuld & Company conducted monthly monitoring and intelligence gathering in a variety of infectious disease areas each year. The post Multi- Year Global Vaccine Monitoring Project?

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Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases. QPS was established in 1995 to provide bioanalytical LC-MS/MS contract services.

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The FDA Law Blog

JANUARY 29, 2023

This means that if your drug manufacturing facility is inspected, it is nearly twice as likely as before that FDA will follow up with regulatory or enforcement action, which can include Warning Letters, freezes on drug approval applications or on issuing export certifications, requests for a recall, seizures, or requests for consent decrees.

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ISPE

JANUARY 30, 2023

The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Trudy Patterson Mon, 01/30/2023 - 10:54 iSpeak Blog iSpeak The Ever-Changing Regulatory & Quality Landscape with Aseptic Processing Michael G. Make plans now to attend the and take advantage of hearing from Industry and Regulatory experts.

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