pharmaphorum

MAY 4, 2021

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. Though pharmaceutical firms and medical device makers have cleaned up their acts, regulatory hasn’t really let up.

Life Science 111

Life Science Compliance Regulation Marketing 111

BioTech 365

DECEMBER 2, 2021

Global High-Integrity Pressure Protection System (HIPPS) Markets 2021-2025: Rise in Midstream Infrastructure and Compliance to Stringent Industrial Regulations Driving Growth – ResearchAndMarkets.com Global High-Integrity Pressure Protection System (HIPPS) Markets 2021-2025: Rise in Midstream Infrastructure and Compliance to Stringent Industrial (..)

Compliance 40

Compliance Regulation Marketing 40

BioPharma Reporter

JANUARY 29, 2024

Naturally with more and more people using it for work, new regulations on data use and management are starting to appear. Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently.

Compliance 104

Compliance Pharma Conference Regulation Marketing 104

XTalks

FEBRUARY 26, 2024

Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health. For stakeholders in the food industry, understanding and adapting to these regulations is not just a matter of compliance but a strategic imperative for business success.

Regulation 59

Regulation Compliance Production Development 59

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health. No product is mentioned for help-seeking advertising.

Marketing 130

Marketing Compliance Doctors Doctor 130

Pharma Marketing Network

JULY 12, 2023

The pharmaceutical industry is facing a number of challenges, including increasing competition, rising costs, and changing regulations. In order to succeed in this challenging environment, pharmaceutical companies need to adopt a patient-centric approach to marketing. They are individuals with unique needs, concerns, and experiences.

Marketing 98

Marketing Compliance Regulation Branding 98

XTalks

DECEMBER 7, 2023

These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. The Food Traceability Rule, a critical aspect of the FDA Food Safety Modernization Act (FSMA) 204, is designed to expedite the detection and rapid removal of potentially hazardous food from the market.

Compliance 59

Compliance Manufacturing Regulation Production 59

Cloudbyz

MAY 17, 2024

As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation. This could challenge the swift market introduction of innovative AI solutions, potentially leading to prolonged development timelines and increased costs.

Life Science 52

Life Science Clinical Trials Clinical Trials Trials 52

Outsourcing Pharma

OCTOBER 16, 2023

AI start-up, Leucine, claims ânot fit for purposeâ compliance protocol processes are hindering the ability to deliver life-saving drugs faster.

Compliance 77

Compliance Drugs Regulation Marketing 77

Pharma Marketing Network

APRIL 21, 2021

The Pharma Marketing Podcast is pleased to present this special guest episode from our friend and Editorial Advisory Board member Darshan Kulkarni, Sales and Marketing Oversight – April 21, 2021. Darshan Kulkarni and Marc Banjak, General Counsel at Dova Pharmaceuticals, discuss sales compliance in the life sciences.

Sales 90

Sales Marketing Life Science Compliance 90

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

XTalks

JANUARY 9, 2024

Swoop , a leader in healthcare marketing, recently introduced a groundbreaking portfolio of predictive AI targeting for pharmaceutical and life sciences advertisers. This capability will usher in a new era in healthcare marketing, moving beyond traditional methods that rely on past data to a future-focused approach.

Marketing 104

Marketing Life Science Compliance Doctors 104

Pharma Marketing Network

OCTOBER 14, 2023

In this article, we will explore the challenges of balancing privacy concerns with targeted ads in pharma marketing. In many countries, there are laws in place that regulate the use of personal data. Companies must ensure that they are in compliance with these laws, or risk being subject to harsh penalties.

Marketing 97

Marketing Compliance Sales Production 97

Outsourcing Pharma

APRIL 11, 2023

OSP spoke to Vladamir Penkrat, head of safety and regulatory and Shuba Rao a senior director at Indegene, a life sciences digital company about a paper they recently published called 'Challenges and Future of PV Compliance' about the direction compliance is headed and how they would convert risk-based approaches into a confidence-based assurances. (..)

Compliance 52

Compliance Life Science Regulation Marketing 52

BioPharma Reporter

JANUARY 29, 2024

Naturally with more and more people using it for work, new regulations on data use and management are starting to appear. Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently.

Compliance 52

Compliance Pharma Conference Regulation Marketing 52

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. On top of this, some regulations have changed, plunging more facilities into the possibility of not complying. Doing so means that businesses can check their compliance before an FDA inspection.

Compliance 88

Compliance Regulation Manufacturing Contamination 88

pharmaphorum

DECEMBER 21, 2023

Patient-centric advertising using zero-party data can provide effective and personalised healthcare marketing while ensuring compliance with legal regulations and industry standards.

Compliance 64

Compliance Regulation Marketing 64

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Finding the best commercial packaging suppliers in contract marketing.

Packaging 130

Packaging Packaging Marketing Containment 130

FDA Law Blog

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.

Marketing 59

Marketing Life Science Compliance Business Development 59

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

FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount.

Compliance 52

Compliance Drugs Regulation FDA Approval 52

Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra. Funding Research on Cannabis.

Regulation 97

Regulation Research Production Cosmetics 97

WCG Clinical

DECEMBER 13, 2023

These supplements are not classified as drugs under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and, as such, do not require pre-marketing approval from the U.S. This is true regardless of whether the product is legally marketed as a food or a dietary supplement. Food and Drug Administration (FDA).

Regulation 52

Regulation Research Production Compliance 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

Marketing 52

Marketing Regulation Compliance Drugs 52

FDA Law Blog

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. Generally speaking, that recognition has limits, however.

Regulation 98

Regulation Compliance Manufacturing Marketing 98

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

Advarra

JUNE 26, 2023

Food and Drug Administration (FDA) guidelines is critical to the success, failure, or delay of delivering life-changing therapies to market. A successful FDA inspection can pave the way for continued operations, product approvals, and in some cases, even accelerated go-to-market regulatory pathways.

Compliance 52

Compliance Regulation Marketing Production 52

FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M.

Cosmetics 64

Cosmetics Production Compliance Regulation 64

The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

Regulation 52

Regulation Compliance Contamination Marketing 52

Pharma in Brief

MAY 4, 2023

The Ontario Superior Court ( ONSC ) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations ) brought by Apotex Inc. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements for damages.

Regulation 52

Regulation Sales Production Compliance 52

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. Sections 4 and 5 work together.

Marketing 52

Marketing Drugs Regulation Compliance 52

Pharma Marketing Network

MAY 3, 2023

The pharmaceutical industry has undergone significant changes in recent years, with digital marketing playing an increasingly important role in the way companies communicate with customers and stakeholders. Another key advantage of digital marketing is the ability to measure and analyze the effectiveness of campaigns in real-time.

Marketing 52

Marketing Compliance Engineer Branding 52

Pharma in Brief

NOVEMBER 16, 2020

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance ( NOC ) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background.

Regulation 52

Regulation Compliance Marketing Licensing 52

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Post-market requirements cover activities such as registration and listing (21 C.F.R. By Adrienne R.

Compliance 98

Compliance Marketing Regulation Development 98

FDA Law Blog

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity.

Regulation 69

Regulation Compliance Marketing 69

pharmaphorum

JUNE 28, 2016

In today’s competitive, highly regulated environment, product success is dependent upon data and fact-based decision making. More and more, Medical Affairs teams play a pivotal role in education pre- and post-launch, yet the explosion of big data in healthcare is changing how we make value-based decisions that are critical to success.

Compliance 52

Compliance Big Data Regulation Production 52