Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 52

Marketing Compliance Packaging Packaging 52

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In addition to granting new drug approvals, the FDA is also the gatekeeper for whether a sponsor can conduct the clinical investigations necessary to gather the data required for drug approval. The IND goes into effect; and .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 40

Marketing Compliance Packaging Packaging 40

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Let’s delve into why this method is paramount for the transformation of clinical research management.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. PRISYM ID is a part of the award-winning Zebra® PartnerConnect program. About PRISYM ID. Media Contact: Andrew Baud, Distil,?

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Cloudbyz

MARCH 30, 2023

However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials. Regulatory compliance Regulatory compliance is critical to the success of cell and gene therapy trials, and there are many regulations to navigate.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. COVID-19 has demonstrated that trials can be run much more efficiently, to everyone’s benefit. Compliance is key.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Advarra

JUNE 28, 2022

There are a myriad of regulations coming into play during the drug development process. Because of this, the FDA understands sponsors may need help making sense of regulations. In order to achieve this, teams must undergo detailed planning and have a strong knowledge base of IND regulations. Inadequate Support.

Regulation 52

Regulation Drugs Manufacturing Development 52

Drug Discovery World

JULY 11, 2022

These challenges exist across the translation cycle from early research to clinical trials, manufacturing, and ultimately reimbursement. The complexities of sample management can significantly extend the timelines for clinical trials. Methods& clinical development, 21,524–529. Regulatory requirements.

Gene Therapy 52

Gene Therapy Gene Development Production 52

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Both the EU and the U.S.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers.

Production 52

Production Manufacturing Vaccination Vaccine 52

The Pharma Data

AUGUST 3, 2021

The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021.

Antibody 52

Antibody Sales Production Development 52

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. and markets outside the U.S.

Production 52

Production Branding Marketing Licensing 52

Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Regulations can be challenging, with ever-changing rules. And accurate labelling and translation are critical for this sector.

Medicine 130

Medicine Production Packaging Packaging 130