ISPE

MAY 1, 2023

Their Quality Management System (QMS) may include multiple policies, standards, procedures, templates, and instructions. On a high level, the validation master plan mentioned that the CSV approach had to be compliant with several regulations and standards and also here is was not clear whether this was consistent with the underlying controls.

Documentation 98

Documentation 98

Pharmaceutical Technology

APRIL 4, 2023

The firm, which is a partner of PharmaJet, has submitted interim safety and immunogenicity endpoints data from the Phase II/III trial to the Indian regulator to secure the EUA. Topic sponsors are not involved in the creation of editorial content. The move follows a rise in the incidence of Covid-19 in India.

Vaccines 59

Vaccines 59

pharmaphorum

AUGUST 18, 2022

Megan Coder is chief policy officer at DTA and a member of the Frontiers Health steering committee. Now the conversation has moved on in [recent] years more to how could these get reimbursed and how are they regulated and how do we get them to market? Far from it.

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97

ISPE

MAY 16, 2023

Below are just a few of the topics that we’ve covered recently. Shared responsibility model: Having well-defined roles and responsibilities between the regulated company and blockchain provider is essential. Procedures should cover access control, data management, audit trail review, and how blockchain integrates into existing systems.

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Compounding 98

Pharmaceutical Technology

MAY 24, 2023

The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

FDA 52

FDA 52

ISPE

NOVEMBER 3, 2022

There is also opportunity for regulators to continue to share information through convergence that may make it possible to provide new therapies on a more global basis. This year’s panel featured regulators from multiple countries and regulatory authorities around the world: Nélio Cézar De Aquino. Global Regulatory Town Hall.

Communication 98

Communication FDA Documentation Vaccines 98

Pharmaceutical Technology

MAY 3, 2023

The regulator has also granted orphan drug designation for the therapy to treat follicular lymphoma (FL). Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

FDA 59

FDA 59

Pharmaceutical Technology

JUNE 8, 2023

Based on past data announcements, all three participants maintained consistent cystic fibrosis transmembrane conductance regulator (CFTR) expression. Topic sponsors are not involved in the creation of editorial content. Both the aerosol delivery and the therapy itself were well tolerated, with no related adverse events.

FDA 98

FDA 98

The FDA Law Blog

MARCH 9, 2023

Farquhar — The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. Monaco’s remarks on DOJ’s new material was worth listening to, as she hit on three topics that added some new deep cuts to the DOJ corporate enforcement catalogue. Second, Ms.

FDA 52

FDA Controlled Substances Documentation 52

Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. Topic sponsors are not involved in the creation of editorial content.

Immunization 52

Immunization 52

ISPE

OCTOBER 28, 2022

According to ISPE Combination Products Communities of Practice Chair Susan Neadle, “a combination product is composed of two or more differently regulated medical products, i.e., constituent parts, that are to be used together, or are being studied for use together, to achieve an intended use, indication, or effect.

FDA 52

FDA 52

pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades.

FDA 52

FDA 52

The FDA Law Blog

NOVEMBER 2, 2023

These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand. The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation.

FDA 59

FDA Packaging Documentation Labelling 59

pharmaphorum

OCTOBER 12, 2022

The group will be leading a workshop on the topic at Frontiers Health next week. In one exercise Albani does with his students, they actually map these different stakeholder priorities in a graph, to help lay out what sorts of things patients value versus regulators versus researchers. Unifying varied stakeholders. Planting seeds.

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110

ISPE

NOVEMBER 23, 2022

The technical sessions kicked off with the session Building a Quality Organization which was led by Christine Moore, Executive Director, External Advocacy & Policy, Organon and 2022 PQLI chair. Raphael Sanches Pereira, Health Regulation and Surveillance Specialist, ANVISA; and Jayda Siggers, Senior Biologist/Evaluator, Health Canada.

FDA 52

FDA Documentation 52

The FDA Law Blog

DECEMBER 12, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).

Documentation 23

Documentation FDA Communication 23

pharmaphorum

AUGUST 12, 2021

” For its part, Pfizer has insisted it is sticking to a tiered pricing policy for its vaccine, “based on factors including volume and delivery dates, which ensures agreements are bespoke to the needs of each vaccination programme we support.” The UK has now fully vaccinated 75% if its adult population.

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Vaccines Immunization 110

ISPE

JULY 24, 2023

But a well-designed cloud application that complies with modern security standards and regulations can actually be more secure than holding data on an internal network. Disclaimer: iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry.

Communication 98

Communication Documentation 98

ISPE

JUNE 14, 2023

This year was a major success with a wide range of topics addressing advancements in technology and policy initiatives that are transforming the pharmaceutical manufacturing landscape. Furthermore, any QMM rating program will be voluntary whereas Quality Metrics are considered mandatory under FDA regulations.

FDA 52

FDA 52

ISPE

SEPTEMBER 1, 2023

But a well-designed cloud application that complies with modern security standards and regulations can actually be more secure than holding data on an internal network. Disclaimer: iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry.

Communication 98

Communication Documentation 98

ISPE

OCTOBER 27, 2022

Digital health is a broadly defined topic that encompasses the application of digital technologies in health care, living, and society to help deliver or provide access to health care products and services. What Is Digital Health? Software as a medical device (SaMD) or software in a medical device (SiMD). Telemedicine or telehealth.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

OCTOBER 27, 2022

Digital health is a broadly defined topic that encompasses the application of digital technologies in health care, living, and society to help deliver or provide access to health care products and services. What Is Digital Health? Software as a medical device (SaMD) or software in a medical device (SiMD). Telemedicine or telehealth.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

BuzzRx

OCTOBER 14, 2022

Customized Medicines When health professionals prescribe multiple medications to apply in the form of topical creams in a particular order or all together, it can be quite inconvenient. Who regulates compounding pharmacies? This can help to prevent the systemic adverse events associated with a drug.

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Compounding Pharmacies Compounding Dosage Sterile Compounds 52

pharmaphorum

JANUARY 17, 2022

Discuss the impact on UK parallel trade following Brexit, through the eyes of regulators, the pharmaceutical industry and academics. Develop further understanding of the rules and regulation changes over the past 12 months, Parallel Trade, where are we now? Policy Patent Operations. Supply Chain Development – Brexit. Purchasing.

Packaging 52

Packaging Vaccines 52

ISPE

NOVEMBER 1, 2022

Zipp spoke next to welcome attendees, who she encouraged to make the most of the meeting through sessions and meeting with colleagues, noting that many key topics are being covered. She also noted that 17 regulators from around the world were attending the meeting. Future regulation should be pragmatic, proactive, and rewarding.

FDA 98

FDA Insurance Chemotherapy Documentation 98

pharmaphorum

OCTOBER 2, 2020

The authors say that in the wake of the pandemic, there is a renewed appetite for proactive self-education on the topic of health; some 50% of respondents said they now feel more able to recognise their body’s symptoms of ill health and 62% are more likely to consider their health in day-to-day decision-making. Ed Hudson, Create Health.

Communication 110

Communication 110

pharmaphorum

NOVEMBER 1, 2021

That’s according Carinne Brouillon Head of Human Pharma and member of the Board of Managing Directors at Boehringer Ingelheim, who spoke during a fireside chat on the topic, held at the online Reuter’s Events Pharma 2021 event. It’s important to remember, she said, that without patients, the pharma industry would not exist.

Communication 76

Communication 76

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.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

JULY 21, 2023

The seminar was organized with opening keynote and plenary presentations followed by three tracks, one for each of the above topics with closing plenary sessions. A lack of understanding of this has led to confusion and uncertainty within the industry and among regulators regarding what this means in practice.

Documentation 98

Documentation 98

Viseven

NOVEMBER 17, 2022

Most importantly, they identify trending topics and provide opinions, insights, and metrics to measure content quality usage metrics to reveal the need to address safety, efficiency, or quality issues before the time ends. Since several therapies are arising, pharmaceutical companies are promising to lead in their transformation.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

APRIL 5, 2023

AZ: How can regulators ensure that they nurture future innovations in the field? Across the world, to varying degrees, the regulations were written in an era of small molecules and biologics. Topic sponsors are not involved in the creation of editorial content. But we need to recognize the challenge of solid tumours.

FDA 59

FDA Immunization 59

Hospital Pharmacy Europe

JANUARY 19, 2023

Key topics included antimicrobial stewardship, mental health challenges and health literacy FIP has had a long-standing commitment to combatting antimicrobial resistance (AMR) and antimicrobial stewardship (AMS) is one of the organisation’s key development goals.

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Community Pharmacies Hospitals Communication Medical Schools 98

pharmaphorum

DECEMBER 22, 2021

Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. The way the body assesses new medicines is going through its biggest change in years, Dr Paul Catchpole, director of value and access policy at the ABPI, told us in April.

Documentation 105

Documentation 105

pharmaphorum

SEPTEMBER 28, 2020

Clinical trial readouts continue to emerge despite countries’ lockdown policies, providing several decision-making challenges for healthcare professionals such as haematologists and oncologists – also known as haem/oncs. Building knowledge and confidence with digital education.

FDA 105

FDA Hospitals 105

Policy Prescription

MAY 28, 2021

NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” The featured speaker was, Shabbir J.

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Mail-Order Pharmacies Pharmaceutical Companies Pharmaceutical Companies FDA 52

pharmaphorum

MARCH 30, 2021

Similarly, Rob has seen a huge growth in exit interviews: “If it’s truly novel, the trial exit interview helps to understand the value, what difference it is making to a patient’s life, and in some cases has helped to convince regulators that the benefits are meaningful and important, and so tip the balance towards the product getting approved”.

Communication 72

Communication Labelling 72

European Pharmaceutical Review

AUGUST 17, 2022

This is why we developed a manufacturing standard ; to minimise the contribution antibiotics manufacturers are making to AMR, even in the absence of any other type of control (eg, government regulation). Overall, our goal with the Alliance is to align this cross-sector life sciences group on the important topic of combatting AMR.

Hospitals 89

Hospitals Pharmaceutical Companies Pharmaceutical Companies 89