Eye on FDA

NOVEMBER 17, 2020

Because the regulatory oversight of COVID became highly politicized, and after some missteps by FDA, some states have indicated that any federal decision will be reviewed, but that does not seem likely to present much a barrier in terms of timeline, if at all. In addition, the process of vaccination takes time.

Communication 81

Communication Vaccines HIPAA Documentation 81

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation 98

Documentation Communication 98

Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

Biosimilars 49

Biosimilars Communication Labelling Documentation 49

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Eye on FDA

OCTOBER 19, 2022

The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern. Communicators and marketers would love black and white answers about concrete platforms. And they believe that the principles laid out to date cover pretty much any communications platform. Small screens.

Communication 89

Communication Documentation 89

Express Pharma

AUGUST 16, 2024

Dr Udaykumar Rakibe, Founder of PharmaMantra, presented on the practical applications of QRM, using real-world examples to explain risk assessment, control measures, and the importance of ongoing risk communication. He emphasised the role of detection in ensuring that substandard products do not reach patients.

Documentation 111

Documentation Communication 111

pharmaphorum

NOVEMBER 15, 2021

That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We The text, the structure of the text, and the presentation of data needs to account for a limited understanding.”.

Documentation 98

Documentation Communication Hospitals 98

PharmD Live

JANUARY 22, 2025

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. Leveraging Telehealth to Expand Practice Income Telehealth technologies present a powerful opportunity to enhance care and boost revenue. Administrative burdens add to these challenges.

Medication Therapy Management (MTM) 59

Medication Therapy Management (MTM) Hospitals Documentation Communication 59

Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). It also improves care coordination and eliminates communication gaps. It involves the training of community paramedics in performing some aspects of medication reconciliation.

Hospitals 130

Hospitals Communication Medical Records Dosage 130

Pharma Marketing Network

OCTOBER 13, 2021

Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals, shared advice with conference attendees on how to Navigate Getting Noticed, Hired and Promoted in a Virtual World. “Do Over-Communicate. Senior Director and Head, Scientific Communications and Operations at Biohaven Pharmaceuticals.

Communication 98

Communication Documentation 98

Express Pharma

DECEMBER 11, 2023

It also showcased why Chandigarh, with a conducive business climate, access to skilled manpower, and good infrastructure, presents an opportunity for pharma companies to expand their horizons. To overcome these hurdles, Dr Gupta advised leaders to collaborate closely with regulatory authorities and proactively address compliance issues.

Packaging 104

Packaging Communication Documentation 104

ID Stewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

Communication 90

Communication Medical Records Inpatient Documentation 90

RX Note

JULY 15, 2023

Introduction Medical/case note entries are legal documentation of all contributions made by healthcare providers in a patient's care. It facilitates effective communication among healthcare providers by enabling the sharing of concise, informative and auditable records.

Documentation 52

Documentation Communication 52

Putting Patients First Blog

APRIL 8, 2025

Sponsors must also communicate how patient data are collected, processed, and used throughout the AI lifecycle, ensuring transparency and maintaining public confidence. While these characteristics can improve diagnostic accuracy and enhance clinical decision-making, they also present novel regulatory challenges that must be addressed.

Documentation 52

Documentation Labelling Communication 52

Eye on FDA

JULY 7, 2020

This year the unprecedented circumstances presented by the COVID-19 pandemic make it particularly interesting this year. The communications vehicle that incurred the violation was a sponsored link that appeared on Google. A good place to start is with regulatory enforcement of the Office of Prescription Drug Promotion (#OPDP).

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

Pharma Marketing Network

MAY 9, 2025

These dossiers must combine: Clinical efficacy and safety data Pharmacoeconomic models Budget impact analyses Comparative effectiveness studies Health economics and outcomes research (HEOR) plays a pivotal role in generating and presenting these data. Teams that wait until launch to assemble this data often fall short in access negotiations.

Packaging 52

Packaging Documentation Communication 52

FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

Documentation 75

Documentation Packaging Communication Labelling 75

FDA Law Blog: Biosimilars

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.

Documentation 59

Documentation Communication 59

Viseven

MARCH 11, 2025

Improve communication with your clients and achieve better customer engagement with our templates ! Effortless document copying with “Edit in eWizard” Our team ensured version accuracy for the localization copy with the MLR-approved content item.

Documentation 52

Documentation Communication 52

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

Documentation 59

Documentation Customer Service Health and Personal Care Stores Communication 59

Viseven

JULY 25, 2024

This includes verifying the evidence presented, the research results, and even the factual information. Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 4, 2023

There are also numerous industry guidance documents for products manufactured for use in clinical trials and guidelines, some which are specific to advanced therapeutic drug products that must be consulted. Teams must also accept the variety of analytical procedures these regulatory agencies prefer.

Drug Development 98

Drug Development Communication Dosage Chemotherapy 98

Viseven

JUNE 18, 2025

Scientific communication : Drafting slide decks, scientific responses, medical information letters, and training content using generative models, ensuring scientific accuracy and compliance in messaging and content.

Labelling 52

Labelling Communication Drug Development Documentation 52

Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. These steps can significantly reduce errors, improve overall compliance, and ensure responsible stewardship of public funds.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Documentation Hospitals Communication 52

pharmaphorum

FEBRUARY 22, 2022

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. Listen deeply, stay present and pay attention to the discussion – not an electronic device. As a participant, arrive on time, too.

Communication 80

Communication Documentation 80

Pharma Pathway

FEBRUARY 2, 2023

Should have exposure in preparing and drawing documents like PDR, MFR, BMR and execution of pilot and pivotal batches. Should have Excellent Oral and written communication and presentation skills. Should have update knowledge and current requirements of various regulatory agencies.

Dosage 59

Dosage Documentation Communication Pharmaceutical Companies 59

PharmaState Academy

MARCH 6, 2024

CASE STUDY Building Trust in Cross-Cultural Sales Interactions Enhancing Interpersonal Skills in Pharmaceutical Sales Table of Contents Case Study Introduction: In the dynamic landscape of pharmaceutical sales, expanding into new regions with diverse cultural backgrounds presents both opportunities and challenges.

Communication 52

Communication Documentation 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. There are drawbacks to the current communication channels: 1.)

Documentation 59

Documentation Labelling Communication 59

PharmaState Academy

MARCH 30, 2023

He is an awe-inspiring peronality who has exceptional experiences in building and leading Institutional Sales, Key Account Management , Strategy & Planning , Market Access, Tender Business, New Product Inclusion, Document & Pricing strategy and much more.

Documentation 52

Documentation Communication 52

pharmaphorum

OCTOBER 4, 2022

4) intended for the purpose of enabling such HCPs to independently review the basis for such recommendations that such software presents, so that it is not the intent that such HCPs rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (Criterion 4). Criterion 3.

Documentation 105

Documentation Labelling Communication 105

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Documentation 52

Documentation Packaging Communication Customer Service 52

pharmaphorum

NOVEMBER 20, 2020

Behind the Mask is a global research initiative to document health experiences during the COVID-19 pandemic and beyond. Havas Health & You (HH&Y) has launched the details of a long-term global research project, Behind the Mask, a longitudinal, multi-armed study that focuses on documenting the ongoing evolution of health and wellness.

Documentation 52

Documentation Communication Medication Delivery 52

Express Pharma

JUNE 20, 2023

However, blood cells do not present the entire picture. Institutional support, such as expert consultants, essential document templates, and protocols for regulatory submissions, is also vital. Studying immune cells in the blood can provide insights into their behaviour and role in pathogen control.

Immunization 105

Immunization Immunity Vaccines Hospitals 105

FDA Law Blog: Biosimilars

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

Communication 53

Communication Documentation Biosimilars 53

FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Two licensed pharmacists must directly communicate the transfer. By Larry K. The content and prescription information elements required by 21 C.F.R.

Controlled Substances 52

Controlled Substances Documentation Communication 52

Eye on FDA

APRIL 17, 2020

But the communication from FDA underscores the possibility. For the present it is a wait-and-see moment for each and every product in the pipeline. However, this will be assessed on an ongoing basis. In the current environment, the only thing that can be said with certainty is that we are dealing with a great deal of uncertainty.

Documentation 55

Documentation Communication 55