ISPE

JUNE 27, 2023

The session included regulators from the European Medicines Agency (EMA), the UK Medicines & Healthcare Products, Regulatory Agency (MHRA), the Spanish Agency of Medicines and Medical Products (AEMPS) and the US Food and Drug Administration (FDA).

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Communication FDA Vaccines 52

ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 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

Pharmaceutical Technology

NOVEMBER 9, 2022

BioMarin’s Roctavian has a target PDUFA action date of March 31 next year. While experts interviewed by Pharmaceutical Technology found the cost-effectiveness estimates valid, the durability of gene therapies in haemophilia remains unclear, particularly in the case of Roctavian, which has faced similar queries from regulatory authorities.

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Roots Analysis

AUGUST 29, 2023

The mechanism of action of such therapies usually involves alteration of genes in specific types of cells and then, their insertion into the patient body. Further, CROs are believed to play a significant role in the successful approval of these drugs in a highly evolving regulatory environment.

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ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M.

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Method Validation Documentation Packaging Compounding 52

PharmaShots

APRIL 17, 2023

Therapeutic treatment may include systemics, both oral or injectable, phototherapy or topicals, but despite a variety of available treatments, many patients remain undertreated or untreated. What is unique about its mechanism of action (MOA)? Daniel Quirk: In September, the U.S.

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FDA Immunization Hospitals 40

ISPE

APRIL 19, 2023

Understanding what tasks can or cannot be used from the commissioning to the qualification phase, making risk analysis-based decisions, verifying that all systems are installed according to the client and regulatory requirements, and ensuring accuracy through collaboration with quality will ultimately save time and money.

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Documentation Communication 52

The Happy PharmD

AUGUST 4, 2023

I’m used to stating what action needs to be taken and then having others listen and follow my choices. But as I drifted out of the management realm, other people assumed the authority to make the calls. One of the topics on our agenda was seeking new members for our committee. I didn’t always agree with their decisions.

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Packaging Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

PharmaShots

MARCH 6, 2023

Put simply, AI is when computers and other machines mimic human cognition, and are capable of learning, thinking, and making decisions or taking actions. In addition, the user can extract the eligibility criteria and other relevant clinical, safety, and regulatory information. Clinical trials are a key topic for these interactions.

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Immunization Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

pharmaphorum

AUGUST 17, 2020

The financial world, like the pharmaceutical industry, must operate within a tightly-defined regulatory environment, and in doing so has proved adept at connecting with its customers. Utilising 3D animation, motion graphics, illustration and data visualisation, Mechanism of Action videos are created to visually explain drug or device impact.

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Communication Insurance Packaging Pharmaceutical Companies 83

Viseven

JUNE 15, 2023

Leverage capturing, reporting, and actioning medical insights. Over 1,400 attendees got an opportunity to learn the hottest trends in omnichannel engagement, global-to-local marketing, automation, data analytics, medical legal regulatory (MLR) review, and many other topics.

Communication 52

Communication 52

ISPE

SEPTEMBER 11, 2023

There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the advantages of advanced and decentralized manufacturing techniques. ™ technologies.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

Druggist

AUGUST 27, 2020

Lozenges containing hexylresorcinol (Strepsils Extra Triple Action) are associated with fewer side effects (ibid). Lozenges increase the production of saliva by sucking action as fast as 1 minute after individuals start to use them. The soothing effect of throat sweets should not be undermined. Buy on Amazon Price incl.

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Compounding 98

PharmaShots

APRIL 26, 2023

mL Mechanism of Action: interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor First Approvals: FDA (Mar 28, 2017), EC (Sep 27, 2017), NMPA (Jun 19, 2020), MHLW (Jan 22, 2018) Originator: Sanofi & Regeneron Revenue Analysis1 Dupixent is developed and commercialized in collaboration with Regeneron. Topical Rxs didn't help.

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Dosage FDA 56

European Pharmaceutical Review

JULY 1, 2022

Diversity and inclusion – pharmaceutical companies may be required to comply with certain legal requirements relating to topics such as inclusion and non-discrimination. Those organisations which demonstrate good ESG policies now will be far better placed to comply with future regulatory developments and avoid penalties.

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Pharmaceutical Companies Pharmaceutical Companies Documentation 88

The FDA Law Blog

OCTOBER 2, 2023

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). By Charles G. Raver & James E. Valentine & Frank J.

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FDA Documentation Labelling Medical Records 64

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Regulatory submission and evaluation of chemistry, manufacturing, and controls (CMC) data may be required for changes that have a higher risk to impact product quality. Tabetha Bonacci, PhD.

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Documentation FDA Communication Packaging 52

ISPE

MAY 11, 2023

The concepts introduced here will be topics for future articles. In principle, a process can access all available data sets within the “information” layer with the appropriate authorization. link] 8 UK Medicines and Healthcare Products Regulatory Agency. “‘GXP’ The four-step approach is introduced as a methodology. March 2018.

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Packaging Documentation Communication Data Entry 52

ISPE

MARCH 7, 2023

Melton, PhD 1 March 2023 The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. It may be necessary to hire subject matter experts to develop and maintain these standards and provide technical support in this fast-moving topic area.

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Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Communication 52

Viseven

JULY 12, 2022

If you regularly google the equivalent topics to become a medical content ninja, you’re in the right place. Generate leads by inviting professionals and non-experts to online events to discuss various topics and trends. Become an Authority with an SEO-Friendly Blog. Write on multiple topics. Be patient. Support.

Communication 52

Communication Documentation Hospitals 52

ISPE

NOVEMBER 30, 2022

This allows more time to plan maintenance proactively or perform a preventative action, thereby avoiding potentially catastrophic failures. The same research survey showed that PPM initiatives have a higher level of adoption by organizations who feel that advanced manufacturing is supported by existing regulatory frameworks.

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Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

JULY 8, 2022

Selenium’s job of neutralizing the hydrogen peroxide produced during thyroid hormone conversion (via the actions of glutathione peroxidase), becomes even more critical when a person has high iodine levels. The build-up of reactive oxygen species in cells can cause damage to DNA or even cell death.

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Dosage Immunization Adverse Reactions Insurance 59

Pharmaceutical Technology

JUNE 22, 2023

The EU previously focused on AMR through the One Health Action Plan, which was released in 2017. Beyond this, AMR was also the topic of talks in the European Parliament during a recent plenary session on 1 June. Baraldi was one of the authors of The Lancet article alongside Årdal.

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Documentation Communication 52

The FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Understanding FDA Emergency Use Authorization (EUA) Transition Plan. This includes EUAs and full marketing authorizations.

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FDA Documentation Patient Care Hospitals 59