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AYUSH Committee, PHD Chamber of Commerce and Industry organised a Conference on Labelling and Packaging Provisions for ASU products recently at PHD House, New Delhi. He also highlighted that a draft notification will soon be coming for the Industry on the indication of packaging.
The session was led by A V Jayakumar, President- Quality, Ajanta Pharma Presentation highlights Jayakumar provided valuable insights from his extensive experience in quality management and regulatory compliance. He recounted his own experience working with investigative teams and the importance of being proactive when handling complaints.
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. Embracing innovation in pharma packaging is vital become future Shivaji Chakraborty, Asst.
Present complex information in lists rather than paragraphs when possible. capitals, bolding and highlighting) to communicate important information. NOTE: The dispensing label must not obscure the active ingredient(s), strength, and expiry date as printed on the manufacturer's packaging. 12 point and above).
The communications vehicle in question was a social media sponsored posting. OPDP took issue with three specific aspects of the promotional communication. First, while presenting the indication in the posting, there was no risk information included in the communication. Pharma communicators take note.
MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The challenge for pharma in reducing its carbon footprint A recent study presented at COP27 , found that just 4% of biotechnology and pharmaceutical companies were currently on track to meet Paris 2030 climate goals, with the pharmaceutical industry being among the world’s largest carbon emitters.
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).
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.???.
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.
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.
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.
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.
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.
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.
Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.
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?
Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).
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.
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.
It is important to devise a plan as early as possible, starting with an assessment of the overall landscape and the opportunities and challenges presented. While there are some similarities and patterns, the overriding fragmentation of the European market means that a successful access strategy must be country-tailored.
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?
It plans to work with the FDA to plan new analyses and further develop a new application package. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). Please check your email to download the Report.
The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplifying technology and site transfer.
A growing ageing population presents many challenges for health services globally that are already buckling under the strain of recovering from Covid-19, and wearable tech is providing a solution. We source as much of the materials as we possibly can locally, even packaging,” he notes. We have the skills. Printing is done in Glasgow.
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Time for change.
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?
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.
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.
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.,
Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. One area in which the problem can be tackled effectively is product packaging. Covert-hologram seals are also atracting interest within the pharmaceutical packaging sector.
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.
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.
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.
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