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

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

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

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

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

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52

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 57

Documentation Communication 57

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

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

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 94

Packaging Communication Documentation 94

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

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

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

ID Stewardship

OCTOBER 14, 2024

brief report, concise communication) will provide structure guidance (number of words, figures/tables, references allowed). Some AI websites to check out include Dall-E for images, ChatGPT or Google Gemini for text, Suno for music generation, Microsoft Copilot for document analysis, and Plus for presentations. Gauthier, Pharm.D.,

Documentation 52

Documentation Communication 52

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 97

Documentation Communication Hospitals 97

Putting Patients First Blog

JANUARY 22, 2024

It can be evaluated using three core principles, which include: Readability : an objective measure of reading difficulty Understandability : the ability of consumers to process and explain key messages Actionability : which ensures consumers can identify what actions they can take based on the information presented.

Documentation 40

Documentation Communication Hospitals 40

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

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

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 57

Documentation Labelling Communication 57

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

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 51

Communication Biosimilars Documentation 51

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 62

Labelling Communication Documentation 62

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

Viseven

SEPTEMBER 6, 2024

Achieving effective communication between a healthcare specialist and a patient is impossible if data the healthcare provider relies on data that can be misunderstood, misinterpreted, and misused. If any piece of data is used after its documentation or creation, it’s crucial that it be attributed to the original source.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Data Entry Communication 52

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

FADIC

JULY 10, 2023

Designed to enhance how you manage tasks and documents and collaborate with your team, Notion AI offers an intelligent and intuitive platform for managing projects, creating databases, and generating insightful reports. is a revolutionary AI tool transforming how businesses and organisations conduct video communications.

Communication 52

Communication Data Entry Customer Service Documentation 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

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

pharmaphorum

JANUARY 26, 2021

The document has been developed by the Davos World Economic Forum (WEF) and the Lung Ambition Alliance, in collaboration with AstraZeneca. Patients need reassurance that lung cancer services are safe and there needs to be investment in COVID-19 free clinical spaces, backed with communication about how services are kept safe.

Documentation 104

Documentation Communication Vaccines 104

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

FADIC

OCTOBER 20, 2023

■ Elderly patients: usually present with more comorbidities, they often suffer from multiple disease, they commonly use more than a few medications. ■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52

Pharmacy Joe

SEPTEMBER 18, 2022

Certain aspects of the job require a quiet space to work, such as creating an in-service or presentation, or drafting a policy or procedure. But for the majority of the day, it is far more effective to be present on the nursing unit, elbow-to-elbow with patients and the care team. Here are three reasons why: 1.

Medical Records 52

Medical Records Inpatient Documentation Communication 52

Pharmacy Joe

SEPTEMBER 18, 2022

Certain aspects of the job require a quiet space to work, such as creating an in-service or presentation, or drafting a policy or procedure. But for the majority of the day, it is far more effective to be present on the nursing unit, elbow-to-elbow with patients and the care team. Here are three reasons why: 1.

Medical Records 52

Medical Records Inpatient Documentation Communication 52

GMPSOP

JUNE 16, 2023

According to USP <1224> , method transfer is defined as the documented process that qualifies a laboratory (RL) to use an analytical method originating from another laboratory (TL), regardless of whether it’s internal or external. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Dosage Communication Method Validation 52