pharmaphorum

NOVEMBER 30, 2022

The biggest gathering of pharma companies in Europe right now on the commercial side, the Veeva Systems Summit permits the sharing of best practices and of new ideas. Facts that they gleaned included: Across Europe, only 52% of HCPs will accept a visit from a pharma company (i.e.

Life Science 98

Life Science Pharma Companies Sales Marketing 98

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

Clinical Trials 130

Clinical Trials Clinical Trials Life Science Trials 130

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharma Marketing Network

SEPTEMBER 14, 2020

Some of the ways that Pharma companies have been using video to bridge the gap in the service of the Rep/HCP conversation include: HCP Peer-to-Peer Thought Leadership. We’ve also seen the video platform used by medical device, pharma companies, and KOLs to: Share best practices and launch new sales methodologies.

Sales 105

Sales Pharma Companies Nurses Compliance 105

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

pharmaphorum

OCTOBER 19, 2022

Companies need to start with a clear business plan/objective, get sponsorship from those in higher leadership roles, and involve the right stakeholders, such as the brand teams, MLR teams, and compliance as early as possible. Agile collaboration internally and externally.

Life Science 97

Life Science Compliance Production Pharma Companies 97

pharmaphorum

JUNE 10, 2022

Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies. However, pharma’s commercial leaders are uniquely positioned to drive the strategic digital shift in patient care journeys. Digital can help ensure that their drugs have the biggest clinical impact.

Marketing 133

Marketing Engineer Bioinformatics Regulation 133

pharmaphorum

APRIL 27, 2022

This is particularly evident in marketing. Instead, companies are increasingly turning to omnichannel marketing to bridge gaps in communication created by the pandemic. In previous years, pharma was largely in charge of the marketing experience, sending reps to meet with customers face-to-face.

Marketing 116

Marketing Sales Production Development 116

pharmaphorum

OCTOBER 3, 2022

Gaurav Kapoor, co-founder and executive vice president of Indegene, tells pharmaphorum how pharma can take lessons from the entertainment industry and prepare for the Metaverse to enhance content engagement. Pharma companies’ customer communication methods require reimagining as technology progresses. About the author.

Branding 116

Branding Doctors Doctor Compliance 116

Pharma Marketing Network

SEPTEMBER 14, 2020

Some of the ways that Pharma companies have been using video to bridge the gap in the service of the Rep/HCP conversation include: HCP Peer-to-Peer Thought Leadership. We’ve also seen the video platform used by medical device, pharma companies, and KOLs to: Share best practices and launch new sales methodologies.

Sales 69

Sales Pharma Companies Nurses Compliance 69

pharmaphorum

NOVEMBER 30, 2020

This means you can get your product to market safely, and faster. Full traceability throughout the lifecycle process ensures audit compliance and increases the chances of a successful submission to the FDA. And, we’re constantly developing it in line with what’s happening in the industry and with the latest standards and regulations.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Compliance 64

Delveinsight

SEPTEMBER 8, 2021

There are several challenges faced by any company entering or persisting in the market, few of which are managerial, statistical, financial, and analytical decisions to be made by a client organization for which they would require people possessing more knowledge in the specified field that can serve as an advantage.

Marketing 52

Marketing Production Sales Life Science 52

XTalks

MAY 6, 2022

The advantages of good clinical data management software systems include: Fast data access: Using an advanced clinical data management platform helps pharma companies be more efficient. Data integrity and compliance: The software needs to comply with regulatory requirements. elluminate Clinical Analytics.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

pharmaphorum

OCTOBER 15, 2020

The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with new ways of working. Bhupinder McJennett, AbbVie.

Compliance 131

Compliance Pharma Companies Marketing Regulation 131

pharmaphorum

JUNE 10, 2021

If pharmaceutical companies’ steady price increases are wholly due to limitless greed or thirst for revenue growth, this certainly is not proven by the actual, factual financial results for these same companies. What’s Next: How Should Pharma Companies Respond?

Manufacturing 105

Manufacturing Pharma Companies Drugs Pharmacy 105

pharmaphorum

JANUARY 3, 2023

In terms of business transformation of the pharma industry, the areas that can see the most immediate effects are: (1) automated data compliance, (2) data sharing, and (3) data monetisation. Automated compliance. New generation DS solutions, using multi-CDN technology, have overcome this issue. Conclusion.

Compliance 105

Compliance Regulation Pharma Companies Genetics 105

Pharma Marketing Network

OCTOBER 26, 2020

Even two years after the introduction of the General Data Protection Regulation (GDPR), the Information Commissioner Office is still fining companies who fail to fully protect their data. There are two sides of the data protection issue facing the pharma industry. What Does Ensuring Compliance Mean for Pharma?

Clinical Trials 96

Clinical Trials Clinical Trials Regulation Pharma Companies 96

XTalks

JANUARY 11, 2021

Companies outsource to gain access to specialized expertise and technology, scale pharmacovigilance (PV) activities, and reduce costs. However, the efficiency and effectiveness of externalized safety activities are below expectations for many biotech and pharma companies.

Pharma Companies 90

Pharma Companies Compliance Clinical Outsourcing Regulation 90

Drug Discovery World

JANUARY 5, 2023

In the past two years, EU regulatory authorities accelerated processes so that vaccines and medicines could be brought to market more quickly. The pandemic shone a spotlight on slow approval processes, revealing that the time taken to get a product approved and to market is too long and protracted in the EU.

Life Science 52

Life Science Production Medicine Compliance 52

pharmaphorum

APRIL 19, 2021

It’s been made possible by an all-hands-on-deck approach from the NHS, academia, regulators and other players in the health system who have worked together to produce clinical data on vaccines and therapies for COVID-19. It is really important and we have seen a lot of pharma companies interested in the UK.

Vaccination 98

Vaccination Vaccine Life Science Antibody 98

XTalks

NOVEMBER 9, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn about the specific compliance requirements, risk assessments and quality management changes mandated by the IVDR.

FDA Approval 64

FDA Approval HR Genotype Life Science 64

Drug Discovery World

AUGUST 10, 2023

Decreasing the time for market approvals has been the biggest area of focus and progress, not least having witnessed biopharma companies with Covid-19 products being able develop and gain regulatory approval in record time. Structured regulatory data is only partly a technical problem; really the challenge ahead is a business process one.

Production 98

Production Life Science Development Manufacturing 98

Placebo Control

SEPTEMBER 3, 2013

Pediatric post-marketing studies have been completed for over 200 compounds in the years since BPCA (2002, offering a reward of 6 months extra market exclusivity/patent life to any drug conducting requested pediatric studies) and PREA (2007, giving FDA power to require pediatric studies) were enacted.

Drugs 40

Drugs Medicine Compliance Trials 40

Pharmaceutical Technology

NOVEMBER 30, 2022

In Annex 1, the regulator stated “Containers should be closed by appropriately validated methods. While this method’s popularity has prevailed for years, the current market environment for leak detection is changing once again. Encouraged by the regulations, the industry is now mid-transition. Time for change.

Containment 130

Containment Manufacturing Production Regulation 130

Pharmaceutical Technology

MARCH 29, 2023

While regulations will be a key influence behind the types of CCIT methods that pharma companies deploy, manufacturers must also weigh up their own requirements for efficiency and quality when choosing a system. blue dye ingress, microbial ingress) towards deterministic ones.

Containment 130

Containment Production Packaging Packaging 130