The life sciences industry is facing numerous challenges, including escalating costs of research and development, increased competition in new markets, expanding regulatory bodies, and increasing public disclosure demands. With these challenges come increased complexity and risk in managing the regulatory information assets that are essential to bringing new drugs to market.
On average, it costs $800 million to $1.2 billion to bring a new drug to market. This cost, along with the costs of managing content, adds up to several billion dollars a year for the industry.
Regulatory agencies are under tremendous pressure to adapt
With a growing number of regulations dictating the path to market, organizations need to stay ahead of the game. Regulatory information management systems can help organizations plan for and execute their compliance strategies. The traditional approach of managing and storing this information in pen-and-paper repositories or Excel documents has a high cost and adverse effects on time to market and patient outcomes.
They need to be agile to absorb new requirements
To stay competitive, life sciences companies must be able to absorb new requirements and quickly adapt their regulatory information management strategies. Regulatory professionals today face a complex and rapidly evolving landscape, including proliferating information sources, variable data quality, and heterogeneous data.
Additionally, information management strategies are often not built to cross organizational boundaries. For example, creating regulatory documents is no longer a discrete activity; it involves a variety of departments within an enterprise and third-party information exchange. Therefore, regulatory information management must be able to accommodate this evolution.
Life sciences companies need to have a flexible RIM system that can adapt to these changes. Increasing complexity of the life sciences regulatory landscape requires an integrated, robust layer of quality and compliance data. With this, life sciences companies can unlock complete control and visibility.
They need to stay close to regulators
As the post- pandemic scrutiny gains attention, life sciences companies need to stay close to regulators. Although vaccines and treatments are helping to contain the outbreak, it is important for these companies to remain vigilant. While general regulatory enforcement has taken a backseat to other priorities, a shift in priorities is occurring in the industry.
In addition, collaboration between the academic, clinical and policy communities is vital. If they do not maintain a strong relationship, they may miss opportunities to collaborate successfully with regulators. This can delay the release of innovative products and lead to delayed patient benefit. Moreover, it can lead to underestimating adverse effects associated with licensed products.
Because life sciences companies are charged with saving the lives of patients, they must stay close to regulators. Working closely with the right legal counsel can help avoid issues before they arise.
They need to maximize internal collaboration
A new era in life sciences has brought new challenges and opportunities for companies. The rise of new digital interactions and the need to respond quickly to emerging threats have sparked an evolution of the life sciences industry. As a result, companies have made significant changes to manufacturing, clinical trials, and patient engagement. These changes require careful consideration of which ones to keep and which ones to roll back.
Organizations must continue to assess the health of their workforces and shift healthy employees to the highest priority jobs. This can include redeploying medical professionals to testing activities, moving training staff to emergency response lines, and boosting research efforts.
Life sciences must harness the power of technology to meet their productivity and efficiency goals. The right technology can help improve productivity, minimize waste, and build patient trust.
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Categories: Life Sciences | Operational Excellence | Continuous Improvement
Keywords and Tags:
#CSAguidelines #computersoftwareassurance #CSVguidelines #CSVtoCSA #lifesciences #continuousimprovement #operationalexcellence #continuousimprovementforlifescienceindustry #RIM
On average, it costs $800 million to $1.2 billion to bring a new drug to market. This cost, along with the costs of managing content, adds up to several billion dollars a year for the industry.
Regulatory agencies are under tremendous pressure to adapt
With a growing number of regulations dictating the path to market, organizations need to stay ahead of the game. Regulatory information management systems can help organizations plan for and execute their compliance strategies. The traditional approach of managing and storing this information in pen-and-paper repositories or Excel documents has a high cost and adverse effects on time to market and patient outcomes.
They need to be agile to absorb new requirements
To stay competitive, life sciences companies must be able to absorb new requirements and quickly adapt their regulatory information management strategies. Regulatory professionals today face a complex and rapidly evolving landscape, including proliferating information sources, variable data quality, and heterogeneous data.
Additionally, information management strategies are often not built to cross organizational boundaries. For example, creating regulatory documents is no longer a discrete activity; it involves a variety of departments within an enterprise and third-party information exchange. Therefore, regulatory information management must be able to accommodate this evolution.
Life sciences companies need to have a flexible RIM system that can adapt to these changes. Increasing complexity of the life sciences regulatory landscape requires an integrated, robust layer of quality and compliance data. With this, life sciences companies can unlock complete control and visibility.
They need to stay close to regulators
As the post- pandemic scrutiny gains attention, life sciences companies need to stay close to regulators. Although vaccines and treatments are helping to contain the outbreak, it is important for these companies to remain vigilant. While general regulatory enforcement has taken a backseat to other priorities, a shift in priorities is occurring in the industry.
In addition, collaboration between the academic, clinical and policy communities is vital. If they do not maintain a strong relationship, they may miss opportunities to collaborate successfully with regulators. This can delay the release of innovative products and lead to delayed patient benefit. Moreover, it can lead to underestimating adverse effects associated with licensed products.
Because life sciences companies are charged with saving the lives of patients, they must stay close to regulators. Working closely with the right legal counsel can help avoid issues before they arise.
They need to maximize internal collaboration
A new era in life sciences has brought new challenges and opportunities for companies. The rise of new digital interactions and the need to respond quickly to emerging threats have sparked an evolution of the life sciences industry. As a result, companies have made significant changes to manufacturing, clinical trials, and patient engagement. These changes require careful consideration of which ones to keep and which ones to roll back.
Organizations must continue to assess the health of their workforces and shift healthy employees to the highest priority jobs. This can include redeploying medical professionals to testing activities, moving training staff to emergency response lines, and boosting research efforts.
Life sciences must harness the power of technology to meet their productivity and efficiency goals. The right technology can help improve productivity, minimize waste, and build patient trust.
Related Reading:
- Operational Excellence FAQ: Why should you modernize regulatory information management in life sciences organizations?
- Challenges in Modernizing Life Sciences Regulatory Information Management Systems
- USFDA Guidance on Life Sciences Regulatory Information Management
- What are the drawbacks if Regulatory Information Management (RIM) of life sciences organizations is not modernized?
- Modernize regulatory information management to improve operational excellence in life science organizations
- How to Overcome Challenges in Life Sciences Regulatory Information Management
- Benefits of modernizing life sciences Regulatory Information Management
- Transitioning from Computer Software Validation (CSV) to Computer Software Assurance (CSA)
Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
Categories: Life Sciences | Operational Excellence | Continuous Improvement
Keywords and Tags:
#CSAguidelines #computersoftwareassurance #CSVguidelines #CSVtoCSA #lifesciences #continuousimprovement #operationalexcellence #continuousimprovementforlifescienceindustry #RIM
