pharmaphorum

JUNE 25, 2021

Molnar, who served as vice president of market access and government affairs at Cognoa, joins the four-year-old trade association at a time when the potential of using DTx to deliver remote healthcare has been thrust into the spotlight by the coronavirus pandemic.

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Impact Pharmaceutical Services

SEPTEMBER 18, 2023

Challenge Bringing new registration-ready drugs through discovery and clinical trials is a resource-intensive process that requires many levels of expertise. Solution Yumanity chose to partner with Syner-G to manage its CMC processes, regulatory requirements, technical development, and FDA GxP compliance through its CMC360 solution.

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FDA 45

ISPE

AUGUST 7, 2023

Cooke, who has over 30 years of experience in international regulatory affairs, with 18 years in leadership roles, took the helm at EMA as director in November 2020, early in the pandemic, after having worked at EMA since 2002, serving as head of inspections initially and then as head of international affairs from 2009 to 2016.

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Vaccines Communication 52

ISPE

SEPTEMBER 8, 2023

Most important, the lack of global regulatory harmonization reduces incentives for industry to invest in these innovations, which, in many ways, limits access of safe, effective, and quality drug products to patients globally. Representatives from regulatory authorities are also encouraged to complete the survey.

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FDA Dosage Documentation Communication 52

European Pharmaceutical Review

MAY 2, 2023

The growing issue of inequitable access is not just an issue of developing or emerging countries either; significant disparities in medicine availability exist within Europe where the time between regulatory approval (marketing authorisation) and true access for patients can vary from a few days to 2.5

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Compounding Pharmaceutical Companies Pharmaceutical Companies Communication 103

ISPE

JUNE 22, 2023

Through virtual and in-person programming, Women in Pharma provides ISPE members the resources necessary to challenge the status quo and make an impact on both a personal and professional level. Here’s what you can look forward to, and what you might have missed.

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Communication Patient Care 98

pharmaphorum

DECEMBER 9, 2021

She rotated through regulatory affairs, external innovation, and self-care R&D. A true advocate for diversity and inclusion, she also sits on the EMEA Leadership Team for Johnson & Johnson’s LGBT+ employee resource group. Heather’s passion for integrated wellness goes beyond her day-to-day responsibilities.

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Packaging 105

Pharmaceutical Technology

SEPTEMBER 2, 2022

For a large company with a lot of resources and an established commercialisation framework, the cost and effort required to add another product into their existing infrastructure may be minor. More often than not, the decision depends on the size of a launcher’s operational base. De-risking drug launch.

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FDA 52

pharmaphorum

JANUARY 25, 2021

It has been thrilling to watch how COVID-19 has catapulted the pace of collaboration among regulatory agencies. To date, we have seen significant cross-industry collaborations to develop standards and new regulatory guidance for acceptable RWE use cases. public education. clinical trial diversity. real-world evidence (RWE).

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Communication Patient Care FDA 124

pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. The most important thing is that you have a framework to be able to identify them, pick them up quickly and around that regulatory framework. We know that there are 3.5

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 110

Omnicell

JANUARY 10, 2023

The ACA—which included 340B expansion to rural and cancer hospitals, orphan drug discount restrictions, and stronger drug pricing enforcement mechanisms—gave the Health Resources and Services Administration (HRSA) some ability to issue regulations.

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Documentation Hospitals 52

ISPE

SEPTEMBER 8, 2023

2023 ISPE Aseptic Conference Regulatory Panel Logan Thomas Fri, 09/08/2023 - 11:35 InTouch September / October 2023 2023 ISPE Aseptic Conference Regulatory Panel Jörg Zimmermann 1 September 2023 On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session.

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FDA Vaccines Documentation 52

European Pharmaceutical Review

SEPTEMBER 29, 2022

Today, manufacturers of pharmaceutical products marketed in the US are required to comply with current good manufacturing practice (cGMP) standards, which represent a regulatory minimum on quality. cGMP standards promote manufacturing and process quality by ensuring that drug products meet the “safe and effective” criteria set forth by FDA.

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Nursing Homes Department of Veterans Affairs FDA Dosage 82

pharmaphorum

MAY 18, 2021

Pre-commercial & Emerging pharma companies may not think they have the resources to match the launch strategies of big pharma. Smaller companies tend to think that they are missing the resources to use similar launch strategies as big pharma, but with the right efficiencies, they can make considerable savings on marketing budgets.”.

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PharmaShots

MAY 24, 2023

Mechanism of Action: CFTR stimulants Originator: Vertex Pharmaceuticals First Approvals: Below mentioned are the first approvals of Trikafta from different regulatory agencies. Regulatory requirements and policies may differ, potentially delaying access to Trikafta in certain regions.

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Insurance Coverage FDA Hospitals Dosage 56

PharmaShots

FEBRUARY 14, 2023

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.

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FDA Insurance Communication 40

PharmaShots

FEBRUARY 14, 2023

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers.

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FDA Insurance Communication 40

ISPE

OCTOBER 28, 2022

He presented “Advancing the Manufacturing of Complex Biologic Products” and discussed the potential of advanced manufacturing, case studies in COVID-19 and individual gene therapy, and resources from the FDA for product developers. At the FDA, Marks said the agency is thinking about ways to streamline some regulatory aspects.

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Vaccines FDA Immunization 52

ISPE

SEPTEMBER 12, 2022

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. 2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. Corporate Regulatory Compliance & Enforcement Advisor. Regulatory Operations and Enforcement Branch (ROEB), Health Canada.

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FDA Documentation Communication 52

pharmaphorum

NOVEMBER 30, 2022

The Veeva Systems Summit is about sales, medical, and marketing – the commercial side of things, but on the development side Veeva also works in clinical data, clinical operations, regulatory, quality, and safety – and it is starting to connect the functional areas. Excellence, coordination, and connection.

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Communication 98

Viseven

MAY 15, 2023

References & Resources. Powered by modular content, eWizard allows your company to reuse pre-approved content blocks and tremendously simplify medical, legal, and regulatory affairs for e-detailing. Images, video, and audio help sales reps engage HCPs with an engaging story. Navigation Menu.

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Pharmaceutical Companies Pharmaceutical Companies Communication Patient Care 52

The FDA Law Blog

DECEMBER 11, 2023

Regulatory affairs professionals with significant expertise in diagnostics are already in short supply. Thus, it is unclear how FDA will have resources to field pre-submissions and the anticipated premarket submissions. This would require a massive increase in staffing and training. [8] of 510(k) decisions, respectively. [13]

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FDA Research Laboratories Documentation 69

PharmaShots

MARCH 9, 2023

Since its launch in 2016, Tivic Health has obtained three regulatory clearances for ClearUP, including FDA 510(k), FDA De Novo, and CE Mark, four patents, and numerous awards. Designation: Vice President and Chief Corporate Affairs Officer Previous company: Pfizer (10 yrs. LinkedIn Total experience: 35 yrs.

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. We also have some strong chapters in the European and US Pharmacopeias for rapid and alternative microbiological methods, but the regulatory part is lagging.

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Vaccines FDA Research Laboratories Documentation 128

ISPE

MARCH 15, 2023

1 This view prioritizes steps that reduce the use of natural resources and the release of undesirable products such as carbon to the atmosphere or plastics to landfills. Department of Economic and Social Affairs: Sustainable Development. 7 An integrative (vs. 7 An integrative (vs. 1 Circular Economy Practitioner Guide. October 2015.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

MARCH 7, 2023

Department of Economic and Social Affairs: Sustainable Development. Some firms have elected to create a central funding pool to resource all related projects, whereas other firms have asked their business to integrate sustainability into their existing business plans. 1 United Nations. October 2015. link] 2 United Nations. March 2004.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

The FDA Law Blog

SEPTEMBER 16, 2022

Brevig, Senior Regulatory Device and Biologics Exper — Earlier this week, President Biden signed Executive Order 14081, titled “ Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” By Holly N.

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FDA 75

pharmaphorum

OCTOBER 11, 2022

The Reuters Pharma event 2022 began as a bustling industry affair yesterday, based out of the Nice Acropolis convention centre on France’s balmy south coast. With speakers gathered from a broad range of departments across the sector, it was a day for listening and noting, but also exploring and even challenging.

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Generic Medicine Compounding 98

Viseven

JULY 12, 2022

A medical website should have enough content resources to generate traffic and constantly increase it. There are three main types of medical website content resources you can use for that: Webinars. Collaborate with other influencers and web resources. Post regularly. Create content plans and schedule articles every month.

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Communication Documentation Hospitals 52

The FDA Law Blog

NOVEMBER 8, 2022

The IMDRF conference was held in early September where Associate Director for International Affairs at CDRH, Melissa Torres, summarized actions members were taking, including working on harmonizing premarket review requirements. In response, Ms. We are too! Understanding FDA Emergency Use Authorization (EUA) Transition Plan.

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FDA Documentation Patient Care Hospitals 59