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- Category: Health Care
Currently India is aggressively adopting ‘Smart life’ where everything is driven by smart technology like artificial intelligence and IoT, but a grave reality still haunts most of the population is lack of basic healthcare facilities. In recent years, many projects and initiatives have been undertaken to improve the quality of life of common people, however, more concrete steps are still required to achieve the dream of ‘Healthy India’.
In a developing country like India, cheaper drugs & affordable healthcare infrastructure models can work wonders because the more it is affordable the more it is accessible. To make things affordable, we need innovation in drugs, developing therapeutic domain and building healthcare facilities. In last couple of decades India has developed a strategy of delivering highest quality drugs at lowest cost to patients within the country and other developing ones.
India revised the patent regime in pharmaceutical sector to comply with the WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 2005,which excluded certain types of chemical entities such as polymorphs and salts combination of drug patentability so as to prevent patent 'evergreening' by large pharmaceutical companies, which can make drugs unaffordable to the general population. Below are the changes that Indian Pharmaceutical Industry has gone through during the pre-compliance (till 2005) and post compliance(after 2005) phases –
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The Coronavirus pandemic is a seminal event of our lifetime that is impacting every aspect of daily life and commerce. Within the life sciences industry, manufacturers are grappling with the cancellation of medical association meetings and the curtailment of in-person conversion opportunities.
Relative to driving key marketing objectives, conference events are relied upon to drive conversions more than any other channel, according to eMarketer. Of note, the second-most relied upon channel for conversions is email, which is also a leading channel for driving engagement.
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Life sciences regulatory compliance in 2020: Taking a holistic view
Life sciences companies are responsible for helping to improve the lives of millions of individuals and are necessarily held to a high standard of public trust. With such high stakes, regulators have made it clear that "paper compliance" is not enough and that companies are expected to maintain a comprehensive, real-time view of their compliance programs’ effectiveness.
The theme for the 2020 life sciences regulatory outlook is for companies to take a broader view of compliance so that these activities are part of a company's overall business strategy. With compliance top of mind for all involved when a new product nears launch, a new system is brought online, or a new business relationship is explored, companies can be better equipped to do more than comply with life sciences regulations. Active compliance can also be a force to support the needs of your teams, and the process and technological tools they use, to be better integrated and aligned in your company's mission.
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- Written by: DigiTrends4U.com
- Category: Health Care
Regulatory affairs professionals play an essential role within the lifecycle of drugs, biologics, and medical devices, helping to demonstrate to regulators (such as the FDA) that these products are safe and effective. From conception and development to approval and launch, each stage of the commercialization process requires individuals with specific expertise, in areas ranging from clinical data collection to capturing and reporting adverse events.
With today’s ever-changing laws and regulations, there’s a growing demand for well-rounded professionals who understand the overall regulatory landscape and can help companies effectively bring products to market.
Developing that understanding requires staying up-to-date on emerging trends within the industry. Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, advises that to stay competitive in regulatory affairs, professionals need an in-depth understanding of how regulations are evolving and how they’re impacting the field. To that end, he recently shared three emerging trends to watch in 2020.