Eye on FDA

APRIL 13, 2022

The recipient of the letter was Bausch Health Companies and it was in regard to two different communications vehicles – one a “DTC video” that appeared on Lifetime TV’s The Balancing Act – and the other the efficacy webpage of the healthcare professional website. The Context. There are a couple of things of note.

Communication 82

Communication Packaging 82

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

Labelling 52

Labelling Packaging Communication Pharmaceutical Companies 52

pharmaphorum

MARCH 16, 2022

Future onsite-and-online conferences present significant decision-making challenges to the pharmaceutical industry, amply demonstrated by the sponsored symposia options, shown in Figure 5, which were available at the 2021 EAACI hybrid conference. Figure 5 Sponsored symposia options at the EAACI hybrid congress 2021.

Communication 98

Communication Packaging 98

pharmaphorum

AUGUST 17, 2020

Clearly, over the last few months, sales reps have had limited in-person access to HCPs, which has presented a challenge. “A Interactions between sales reps and HCPs has shifted to more digital forms of communication as a result of the lack of face-to-face interaction. Joanna Carlish. Personalising marketing content.

Communication 97

Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 97

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

European Pharmaceutical Review

APRIL 2, 2025

Large datasets of well curated data, presented in the same format, are particularly amenable to profiling by AI systems. AI-based optic systems, for example, can enhance defect screening in manufacturing by scanning for packaging defects. Nature Communications. cited 2025Feb]. Available from: [link] 15. 2020; 11(1): 233.

Packaging 52

Packaging Communication 52

pharmaphorum

MAY 24, 2021

It can be used for sales, marketing and patient communication materials, in print or digital form. It means that designs can be carried out in a more templated fashion than at present and presents a change from marketing-as-usual.

Communication 102

Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 102

pharmaphorum

MAY 27, 2022

Teams and Zoom became the backbone of communication and firms embraced new ways of working. 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.

Packaging 80

Packaging Generic Medicine Communication Hospitals 80

GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials.

Packaging 52

Packaging Documentation Labelling Dosage 52

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

Labelling 40

Labelling Packaging Communication Pharmaceutical Companies 40

Viseven

FEBRUARY 17, 2025

The Viseven team will shine a light on IVAs in pharmacy their role, how to design, adopt, and present them during HCPs’ meetings. These are a key part of e-detailing, which involves using digital platforms for presentations to HCPs. IVAs make it easier to communicate ideas between these key stakeholders.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Dosage 52

pharmaphorum

APRIL 11, 2022

Such therapies present significant challenges to our current regulatory and access processes, but these are challenges we must overcome if patients are to benefit. Data will always be central to everything we do, as it has the power to communicate the potential of a new treatment to change a person’s life.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

pharmaphorum

NOVEMBER 29, 2021

From clear communication with an unsettled, dispersed workforce to maintaining positive energy and managing people’s working hours, the need for open, inclusive and empathetic leadership has never been more important. . iii] It’s no longer just about the company, compensation package and secondary benefits (e.g., gym membership).

Communication 98

Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

FEBRUARY 3, 2023

One important advancement will involve tackling the still-present issue of empty capsids, for example. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. We may still continue to send you service-related and other non-promotional communications. 1] BioNews. Hemophilia News Today. link] [2] Tang Q, et al.

Communication 97

Communication Dosage Packaging Vaccines 97

Pharmaceutical Technology

AUGUST 10, 2022

Expectations should be clearly communicated to the service providers as early as possible. Packaging needs?. Important items to look out for in the proposal include information on what was requested in terms of batch size, number of batches expected per year, component confirmation, and the packaging plan.???.

Packaging 52

Packaging Communication 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 for effectiveness, and communicated to a larger audience. – Assessment of packaging and labeling components.

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. – Assessment of packaging and labeling components.

Documentation 52

Documentation Packaging Communication Customer Service 52

European Pharmaceutical Review

JANUARY 25, 2024

7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Even in countries with high smartphone usage such as Denmark, up to 25 percent of the population do not possess a smartphone.

Packaging 98

Packaging Documentation Communication Pharmaceutical Companies 98

Viseven

AUGUST 15, 2024

Engagement can lead to improvements in drug delivery methods, packaging designs, and support services that enhance the overall patient experience. Utilize digital tools Digital engagement tools, such as patient portals and mobile applications , can facilitate direct communication between patients and healthcare providers.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Drug Development 52

FADIC

JULY 14, 2024

Link Pharmacy Times OTC Guide The OTC Guide®, presented by Pharmacy Times is the premier resource for the top recommended OTC products designed to help consumers make informed decisions. This requires staying updated on the latest information through continuing education and communicating with other healthcare professionals.

Adverse Reactions 105

Adverse Reactions Dosage Mayo Clinic Medical Schools 105

European Pharmaceutical Review

JUNE 24, 2022

Stakeholders in the EU often use the risk-adjusted Net Present Value (rNPV) investment model to determine whether to invest in a pharmaceutical product. This obviously presents a huge magnitude of risk for drug developers,” he noted. It is too early to say because we have not seen the whole package of measures yet. References.

Compounding 105

Compounding Drug Development Drug Pricing Dosage 105

European Pharmaceutical Review

MARCH 28, 2024

Measuring treatment effect in rare disease populations presents many methodological challenges due to small sample sizes and heterogeneity of the study population. How does the qualification package support more meaningful endpoints and rare disease research as a result?

Insurance Coverage and Processing 52

Insurance Coverage and Processing Packaging Communication 52

Pharmaceutical Technology

NOVEMBER 9, 2022

The potential benefits from linking these data streams to AI, meanwhile, cannot be overstated – offering opportunities to predict future scenarios as well as fine-tune orders in the present. As Palmadottir says: “having better technology means we will have better connectivity in real time, and a better network for communication.”

Vaccines 52

Vaccines Packaging Communication 52

pharmaphorum

AUGUST 1, 2022

Ties Kroezen, venture leader of Community Life Centers and business development manager for Philips Africa, tells us about the challenges present within the African healthcare system, solutions the company developed to help patients and providers connect, and how pharma can assist with delivering better care to African residents.

Packaging 78

Packaging Communication Hospitals 78

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

GMPSOP

JUNE 16, 2023

What are the responsibilities for transferring laboratory (TL) Before initiating the method transfer, the TL must provide the RL with a comprehensive transfer package. QA maintains communication between the laboratories. The results of this evaluation are communicated to the TL. What is the analytical method transfer protocol?

Documentation 52

Documentation Dosage Communication Method Validation 52

Quality Matters

MAY 23, 2023

This alone can present serious risks to patients’ health and public health. They include the potential for substandard packaging and shipment, falsification of product information and markings, detection of undeclared chemicals, high variability of quality across samples, and payment for orders being subject to fraud.

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

GMPSOP

MARCH 4, 2023

According to FDA Guidance for Industry – Q9 Quality Risk Management , “Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. How to communicate risk? What is quality risk management in pharmaceutical?

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. No, this will be a violation of good laboratory practice.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

ID Stewardship

NOVEMBER 29, 2023

I was always the technologist training someone, giving information about package inserts about the behind the scenes , talking about why do we do this or why do we do that and that’s the way that I am. I talk to people presenting posters, reach out to speakers, and I give things like stickers with the podcast logo and QR code.

Hospitals 98

Hospitals Packaging Communication 98

GMPSOP

DECEMBER 6, 2024

Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine. – Communicating the location of the spill kit to all staff in the area. formalin) present a threat due to vapors. Major spills These involve serious chemical releases. – Some chemicals (e.g.,

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. . – High-Speed Tablet/Capsule Counting Machines (Critical for accurate counting and packaging of tablets and capsules).

Documentation 52

Documentation Dosage Labelling Data Entry 52

GMPSOP

JULY 14, 2023

In other areas, such as in secondary packaging or in material storage areas, the product isn’t exposed to the environment, so there is a lower risk of contamination. via visual inspection or by communication with the responsible personnel). in the next batch or campaign record). – Has been cleaned. – Is visibly clean.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Pharma Marketing Network

OCTOBER 27, 2020

you say there’s access to all sorts of University high-end University courses and classes on writing and communication among a thousand other topics could you touch a little bit on that and give us some insight into how you hacked your own education in your journey to becoming a thought leader? Robin (Guest): Yup.

Hospitals 52

Hospitals Packaging Communication Diabetes 52

Pharma Marketing Network

OCTOBER 27, 2020

you say there’s access to all sorts of University high-end University courses and classes on writing and communication among a thousand other topics could you touch a little bit on that and give us some insight into how you hacked your own education in your journey to becoming a thought leader? Robin (Guest): Yup.

Hospitals 52

Hospitals Packaging Communication Diabetes 52

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

Health and Personal Care Stores 99

Health and Personal Care Stores Immunity Immunization Compounding 99