pharmaphorum

MAY 25, 2022

The move to online international meetings has left pharma companies with uncertainty around contact compliance. To say the world of work has changed is something of an understatement in the pharma and biopharma industry. But new joint guidance, from the IFPMA, EFPIA, and PhRMA, provides clarity.

Regulation 105

Regulation Compliance Manufacturing Medicine 105

Intouch Solutions

APRIL 11, 2024

Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management. Facilitating cost containment and expediting the content approval process in accordance with regulatory compliance.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

Placebo Control

JULY 31, 2013

In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in.

Pharma Companies 40

Pharma Companies Trials Compliance Clinical Trials 40

Pharmaceutical Technology

DECEMBER 21, 2022

But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances. According to a cross-sectorial survey by the consulting firm Mckinsey & Company , 52% of respondents reported investing in AI this year compared to 40% in 2018.

Regulation 351

Regulation Pharma Companies Medicine Clinical Trials 351

pharmaphorum

JANUARY 8, 2021

The global pandemic has caused pharma companies to invest in digital marketing, as healthcare systems across the world adapt to strict lockdown rules. Healthcare companies have been in the vanguard of this change, with an enormous rise in the use of telehealth and all forms of digital communications. Will we go back to that?

Marketing 96

Marketing Doctors Doctor Pharma Companies 96

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

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

Camargo

NOVEMBER 11, 2020

In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Manager of Regulatory Compliance. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc.

Development 242

Development Bioequivalency Generic Drugs Production 242

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. That, he said, is commercial excellence.

Life Science 98

Life Science Pharma Companies Sales Marketing 98

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 79

Clinical Trials Clinical Trials Trials Packaging 79

Drug Discovery World

FEBRUARY 20, 2024

An obvious opportunity could be to demonstrate the interoperability of BlockSent with EDC systems that are commonly used in clinical trials by pharma companies and to combine BlockSent with a blockchain network offering a smart contract 15 capability. Ther Innov Regul Sci. 2020; 54: 1123-1133.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Pharma Companies 52

Drug Discovery World

FEBRUARY 20, 2024

An obvious opportunity could be to demonstrate the interoperability of BlockSent with EDC systems that are commonly used in clinical trials by pharma companies and to combine BlockSent with a blockchain network offering a smart contract 15 capability. Ther Innov Regul Sci. Informed consent in the future. 2020; 54: 1123-1133.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Pharma Companies 52

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

Drug Discovery World

JANUARY 5, 2023

Enhanced data flows – internally and externally in exchanges with regulators, supply-chain partners, healthcare providers and ultimately patients – will pave the way for process transformation. This has implications for compliance and patient safety, as well as for operational and commercial efficiency. .

Life Science 52

Life Science Production Medicine Compliance 52

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

NOVEMBER 23, 2020

Pharma companies, healthcare providers and governments share a well-established common purpose: the desire to make disease a thing of the past. I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies.

Pharma Companies 128

Pharma Companies Regulation Development Compliance 128

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

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.

Branding 115

Branding Doctors Doctor Compliance 115

Drug Discovery World

AUGUST 23, 2023

At first, they replaced important paper-based processes: labs needed to capture data to manage experiments, comply with regulations, and – pressingly from a business perspective – file patents. In this metaphor, that’s the regulatory, compliance goals of data management achieved. That’s good!

Laboratory Information Management System 52

Laboratory Information Management System Scientist Compliance Development 52

pharmaphorum

JUNE 10, 2022

To compete now, companies need to own a larger portion of the treatment journey and the overall patient care experience. Commercial leaders should leverage the internal capabilities and centres of excellence that pharma companies are increasingly building. About BrightInsight.

Marketing 133

Marketing Engineer Bioinformatics Regulation 133

Delveinsight

SEPTEMBER 8, 2021

Pharma Consultants come up with various business strategies, technical or non-technical, management of quality control & testing, identifying relevant supplies and equipment, drug – design & development, and regulation of clinical trials. Market Assessment & Operational Sales.

Marketing 52

Marketing Production Sales Life Science 52

Drug Discovery World

AUGUST 10, 2023

Thinking about the key potential consumers of data will help build its value beyond the regulatory compliance use case, and shift regulatory’s role within the enterprise as a data producer. What frustrates you in terms of what companies still haven’t realised, or aren’t doing – and what should they do differently in 2023?

Production 98

Production Life Science Development Manufacturing 98

pharmaphorum

NOVEMBER 30, 2020

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. For example, the differences between versions of the same standard.

Clinical Trials 60

Clinical Trials Clinical Trials Trials Compliance 60

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 Risk-Based Quality Management.

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

APRIL 27, 2022

“We’ll find newer and novel ways to engage with our customers, whether it’s advertising on their computers, social media, or whether it involves regulation and guidelines changing even further to understand this new weird world we live in.” ” About the interviewees. Matt Beckett is managing director at CSL.

Marketing 115

Marketing Sales Production Development 115

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. Challenges. New generation DS solutions, using multi-CDN technology, have overcome this issue. Conclusion.

Compliance 104

Compliance Regulation Pharma Companies Genetics 104

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? About the author.

Manufacturing 105

Manufacturing Pharma Companies Drugs Pharmacy 105

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

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

Placebo Control

SEPTEMBER 3, 2013

While FDASIA did not advance PREA in terms of more rigorously defining the scope of pediatric requirements (or, better yet, requiring FDA to do so), it did address one lingering concern by requiring that FDA publish non-compliance letters for sponsors that do not meet their commitments. Have they really not provided feedback in over 2.5

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. Encouraged by the regulations, the industry is now mid-transition. The company also offers a unique tracer gas solution based on helium mass spectroscopy, ideal for early-stage laboratory testing due to its high sensitivity.

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

pharmaphorum

NOVEMBER 7, 2021

Most pharma companies operating in the US have said they will require all employees and contractors to be fully vaccinated against COVID-19 unless they have medical or religious reasons for opting and also agree to other measures such as weekly testing.

Vaccination 52

Vaccination Vaccine Compliance Pharma Companies 52