European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Ethical leadership is essential in promoting a culture of integrity within an organisation. How can this be mitigated?

Government 98

Government Pharma Training Ethics 98

pharmaphorum

NOVEMBER 16, 2022

So, really,” he continued, “[there are] three major take-homes to talk about: first efficacy, then function, and then safety. Additionally,] in my opinion probably the most important safety angle to consider is rates of wet AMD [age-related macular degeneration] were increased with pegcetacoplan treatment, that is 12.2%, 6.7%, and 3.1%

Safety 105

Safety Patients Prospecting Consulting 105

Nixon Gwilt Law

APRIL 22, 2024

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. FDA’s guidance on SaMD, CDSS, and other mobile applications does not contemplate the advent of generative AI technologies.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Nixon Gwilt Law

APRIL 22, 2024

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. FDA’s guidance on SaMD, CDSS, and other mobile applications does not contemplate the advent of generative AI technologies.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Pharma Marketing Network

JANUARY 9, 2025

In an industry where lives are at stake, marketing teams must prioritize transparency, ethical practices, and compliance to build lasting relationships. Adhering to regulations like GDPR and HIPAA ensures your campaigns are both ethical and secure. Transparency in Advertising: Patients and HCPs value honesty.

Marketing 52

Marketing Pharmaceutical Pharma Ethics 52

Pharmaceutical Technology

JANUARY 23, 2023

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59

Medical Ethics Specialization Physicians 59

PM360

JUNE 24, 2024

Regulatory Compliance and Ethical Considerations It may sound like an obvious statement, but to engage patient audiences as a commercial entity, someone needs to keep a regulatory eye on the program. Food & Drug Administration (FDA). It’s better to pay a good one than to receive a letter from the FDA.

Marketing 52

Marketing Patients Food and Drug Administration Digital Media 52

Clarivate

NOVEMBER 13, 2023

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. We developed or explored over 100 COAs and achieved ethical approval in multiple countries including the U.S., All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Pharma Marketing Network

MARCH 20, 2025

Regulatory frameworks such as HIPAA, GDPR, and FDA guidelines dictate how pharmaceutical brands can advertise and engage with healthcare professionals (HCPs) and patients. Consent-driven marketing practices, such as opt-in mechanisms, help maintain ethical advertising standards.

Marketing 52

Marketing Healthcare Healthcare Pharma 52

Rep-Lite

MAY 10, 2024

In recent years, shifts in healthcare regulations, including updates in FDA guidelines and compliance standards, have significantly impacted sales representatives and healthcare providers alike. Don’t get it wrong, these are all aimed at ensuring patient safety, transparency, and ethical standards.

Medical sales 52

Medical sales Sales Medical Medical sales reps 52

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

Clarivate

JUNE 21, 2023

Under the AI Act, medical or in vitro diagnostic medical devices that are AI-powered or incorporate AI as a safety component come under both the MDR/IVDR and the AI Act. Medtech developers will need to obtain relevant certificates to show that their AI technologies meet the required standards of safety, accuracy, reliability, and ethics.

Medical 52

Medical Safety Healthcare Healthcare 52

pharmaphorum

NOVEMBER 3, 2022

Food and Drug Administration’s (FDA) draft guidance, “ Digital Health Technologies for Remote Data Acquisition in Clinical Investigations ”. We see how digital measures of adherence ensure that sample size calculations hold and drug developers can accurately evaluate the safety and efficacy of new molecules.

Pharma 81

Pharma Medicine Education Recruitment 81

Pharma Marketing Network

OCTOBER 3, 2024

Marketers must navigate complex relationships with healthcare providers, patients, and regulatory bodies, ensuring that their strategies align with the ethical standards and legal requirements of the industry. This demands a proactive approach to staying updated with industry trends and innovations.

Marketing 52

Marketing Pharmaceutical Healthcare Healthcare 52

Pharma Marketing Network

DECEMBER 19, 2024

Marketing to HCPs requires a professional yet empathetic tone that highlights a drugs clinical efficacy and safety profile. Providers: Emphasize clinical trial data, safety profiles, and patient outcomes to build credibility. Solution: Partner with legal and compliance teams to ensure all campaigns adhere to FDA and HIPAA guidelines.

Marketing 52

Marketing Pharma Patients Media 52

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

MedReps

SEPTEMBER 19, 2022

First, they’ll likely have more interest in learning about what you sell and second, they’ll be more hesitant to try it because of concerns about insurance coverage, efficacy and safety. In other words, you can face a harsh competitive environment if you work with an ethical company with a supportive culture.

Medical sales 66

Medical sales Medical sales reps Sales Medical 66

Pharma Marketing Network

OCTOBER 1, 2024

One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients. Pharma companies that demonstrate a commitment to sustainability and ethical practices will likely gain a competitive advantage and build stronger connections with their audience.

Marketing 52

Marketing Pharma Media Education 52

Rep-Lite

SEPTEMBER 21, 2024

Navigating Compliance and Regulations in Medical Sales Navigating compliance in medical sales involves adhering to strict regulations, including those set by the Food and Drug Administration (FDA) and the Health Insurance Portability and Accountability Act (HIPAA). These ensure product safety and the protection of patient data.

Medical sales 52

Medical sales Sales Medical Medical sales reps 52

Nixon Gwilt Law

NOVEMBER 28, 2023

This includes steering clear of any instructions that could potentially bypass or interfere with OpenAI’s safety systems. In addition, irresponsible or improper use of this technology in the healthcare context could impact both patient safety and patient privacy. Implement OpenAI’s free moderation endpoint and safety best practices.

Healthcare 52

Healthcare Healthcare Medical Patients 52

pharmaphorum

AUGUST 19, 2022

Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development. Yet we remain unprepared to access reliable and trustworthy sensor data at scale.

Medicine 52

Medicine Healthcare Healthcare Ethics 52

PM360

JUNE 11, 2022

For example, everyone must be steeped in both FDA and FTC guidelines. Then, the MRL team and the influencer must align on where there is flexibility within messaging while still abiding to brand safety guidelines, as you don’t want to lose the authenticity that the influencer brings.

Patients 59

Patients Pharma Education Media 59

Pharma Marketing Network

MARCH 6, 2025

Patient Education Instagram, Facebook, and TikTok help spread disease awareness and medication safety information. Follow FDA and HIPAA Guidelines No misleading claims Every medical statement must be backed by FDA-approved data. Patients trust online communities for treatment discussions, symptom management, and drug reviews.

Media 52

Media Pharma Education Networking 52

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Since then, animal-based testing has been the gold standard for establishing a drug’s safety and efficacy. Then, of course, there are the ethical considerations. Works cited Anon.,

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

Pharmaceutical Technology

DECEMBER 21, 2022

This could spell high-stake consequences for consumers whose privacy and safety could be at risk if AI models are not regulated. FDA and EMA action. However, despite increasing AI adoption, there has reportedly been no substantial increase in AI-related risk mitigation for companies that used AI in at least one function since 2019.

Pharma 140

Pharma Pharmaceutical Medicine Government 140

Clarify Health

DECEMBER 13, 2022

And, as you get into more specialty and rare conditions, the need from a cost, ethical, and frankly just a workflow perspective is only going to increase,” Mr. Clapsis added. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? It’s not just the FDA,” he said.

Recruitment 52

Recruitment Retail Patients FDA 52

Clarify Health

DECEMBER 13, 2022

And, as you get into more specialty and rare conditions, the need from a cost, ethical, and frankly just a workflow perspective is only going to increase,” Mr. Clapsis added. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? It’s not just the FDA,” he said.

Recruitment 40

Recruitment Retail Patients FDA 40

European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

Food and Drug Administration 97

Food and Drug Administration Safety FDA Ethics 97

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. As these drugs are not licensed for the specific indication of gender-affirming care, collecting safety data on off-label use is not viewed as a priority.

Prescription 144

Prescription Ethics Safety Healthcare 144