National Association of Boards of Pharmacy

APRIL 3, 2024

Steps your business can take to prepare for an on-site inspection, accreditation, or review can include: Review Policies and Procedures (P&Ps) to ensure they are consistent with business operations. Review P&Ps P&Ps must be consistent with laws and regulations, as well as accreditation standards, if applicable.

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Documentation 45

Pharmaceutical Technology

MAY 22, 2023

Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing. We offer our sincere gratitude to DEB patients, caregivers, investigators, US regulators and our employees who made this approval possible.

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Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals stated that the fast-track designation enables increased communication with the regulator across the development cycle of the gene therapy. Topic sponsors are not involved in the creation of editorial content. An estimated 50,000 people in Europe and the US are affected by PKP2-ACM.

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Communication 59

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. Major Policy Initiatives. (a) c) Other policy developments. Introduction.

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Drug Channels

JULY 17, 2023

This annual event provides you and your team unparalleled access to the government regulators creating the rules, policies and regulations, the industry leaders tasked with interpreting them and the manufacturer experts who will be implementing them.

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Drug Pricing 40

Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite.

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Biosimilars 62

Pharmaceutical Technology

APRIL 18, 2023

Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients. Topic sponsors are not involved in the creation of editorial content.

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Labelling 52

Express Pharma

NOVEMBER 29, 2023

The signature trade expo, South Asia’s largest and most comprehensive pharma congregation, brought together a vast assembly of industry experts, top manufacturers, the buyer’s community, policy advisors, and key stakeholders, uniting suppliers, innovators, and pharmaceutical leaders.

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Packaging Pharmaceutical Manufacturing 108

Drug Channels

NOVEMBER 30, 2020

Staying on the pulse of industry trends, policies and changing regulations has never been more crucial. With drug pricing and benefit coverage top of mind for many Americans, coupled with a volatile election and overall healthcare landscape, the stakes are incredibly high for bio/pharma manufacturers.

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Drug Pricing 52

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.

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Vaccines 59

Drug Channels

MARCH 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Plus, assess how companies are internally planning for these changes. .*

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Drug Pricing 84

Quality Matters

MAY 25, 2023

The risk of pharmaceutical impurities that can have serious negative health consequences for patients has become a significant challenge for industry, regulators, pharmacopoeias, and other stakeholders in recent years. These include continued cooperation among global regulators, industry, and other stakeholders.

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Communication 52

Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. pCPA incorporates.

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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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Putting Patients First Blog

FEBRUARY 8, 2024

Moving forward, the patient community expects to be included and engaged with policymakers to craft appropriate policies that assure that patients – the end users of health care – benefit from, and are protected from, the use of AI in health care. We promote increased access to affordable, high-value, equitable, and sustainable health care.

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Quality Matters

APRIL 18, 2024

This includes a focus on ESG topics most relevant to USP’s operations, standard-setting activities, our stakeholders’ expectations and priorities, and – most importantly – where USP’s work can have a disproportionately positive impact.

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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.

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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.

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Pharma in Brief

JANUARY 24, 2021

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2020. The year saw the first trials and decisions in actions under the new Patented Medicines (Notice of Compliance) Regulations ( PM(NOC) Regulations ). Major Policy Initiatives. (a) Introduction.

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FDA Law Blog: Biosimilars

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.

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Controlled Substances Documentation 52

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.

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Diabetes 98

Drug Channels

AUGUST 9, 2021

Informa Connect’s 26th Annual Medicaid Drug Rebate Program — MDRP 2021 Hybrid — is an important event for government pricing, rebates and regulation, providing direct access to government regulators creating the rules, the industry leaders interpreting them and the manufacturer experts implementing them. View the agenda here.

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Drug Pricing 40

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.

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Immunity Immunization Diabetes 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.

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FDA Law Blog: Biosimilars

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.

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Pharma in Brief

OCTOBER 25, 2020

On Friday, October 23, the Patented Medicine Prices Review Board ( PMPRB ) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments ). Changes to the Guidelines.

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Biosimilars Documentation Vaccines 52

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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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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Quality Matters

APRIL 25, 2024

International attention on medicine quality and policy reforms This is an exciting time for India, of course, and for the potential for improving the global supply of quality medicines.

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Pharmaceutical Manufacturing 52

GMPSOP

FEBRUARY 10, 2024

FDA-regulated industries should prepare GMP Training policies and procedures for their employees outlining training approaches, scope, responsibilities and overall training system. Types of GMP training for employees GMP-regulated businesses carefully determine what type of training is practical and reasonable for their staff.

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PharmaState Academy

MARCH 6, 2024

This topic was chosen due to its relevance in maintaining brand reputation, fostering collaboration, and driving success in pharmaceutical sales. By examining multiple cases, we aim to provide insights into effective strategies for addressing conflicts diplomatically and rebuilding positive relationships with KOLs.

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Communication 52

Quality Matters

OCTOBER 24, 2023

The event spotlighted perspectives from manufacturers, regulators, healthcare providers, legislators, academia and patients, and issued a call to action for stakeholders to come together to advance needed reforms. These and other recommendations are outlined in a recent USP policy position paper. “We 26 by the U.S.

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Chemotherapy Hospitals 64

Quality Matters

MAY 23, 2023

Members of the APEC panel on the topic discussed illegal online pharmacies as a “whole of Internet problem” with nearly overwhelming size and scale. Research also can support evidence-based policy making, and proactive prevention measures to promote a safe and robust supply chain.

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Online Pharmacies Controlled Substances Packaging Communication 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.

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Packaging Vaccines 52

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.

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Communication Diabetes 109

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.

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Communication Drug Development 71

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.

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