About Insider Talks
An open forum where ProPharma Group’s industry experts share their insights on timely topics. Pharmaceutical, biotechnology, and medical device companies gain new ideas and perspectives to help tackle complex challenges and deliver on our higher purpose of improving the health and safety of patients. Register now for new upcoming events, or to see past recordings.
AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information CapabilityThe expectation for higher coverage and engagement with MI specialists in real-time requires MI teams to adapt to new technologies to provide an optimized customer experience. AI can enable MI Contact Centers to transform the customer experience using digital avenues, thus helping create a truly scalable and global Medical Information capability. January 2022, 11am ET / 5pm CET COMING SOON
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Expedited Programs Explained: How to Expedite Product Approval in the US and Europe
Regulatory agencies across the globe have developed a number of programs and regulatory tools designed to expedite the approval of products likely to be of significant therapeutic benefit. Could your product be eligible for one of these expedited programs?
Navigating the IVDR Medical Device Regulation – How Will IVDR Impact Medical Device Products and Manufacturing in EU and US?
The end of this transition period is May 2022, leaving manufacturers with little time before their technical documentation needs to be updated to comply with the regulations and meet the new, more stringent requirements. What will be the impact of this change for manufacturers with products in the EU and what do we expect for US markets?
FDA Inspection Readiness: A Guide to Preparing for Success and Overcoming Remediation
Adverse findings during an FDA inspection can have catastrophic results to not only the department/team targeted by the findings but also management and the overall company. Each and every associate within the organization is responsible for being compliant and having the skill and knowledge to properly interact with inspectors and manage the inspection process.
Where Medical Device Regulation is Headed – Taking the Mystery out of Changes in the EU and US
On May 26, 2021, the Medical Device Regulation (MDR) takes effect in the EU, resulting in many new regulatory requirements for medical device developers. In this Insider Talks, our experts will dive into what these changes are and how to adapt appropriately to ensure the success of your medical device.
Bring Life-Saving COVID-19 Vaccines and Treatments to Patients Faster
While regulatory authorities perform a vital role to ensure the quality, safety, and efficacy of COVID-19 vaccines and treatments, the process of getting these therapies developed, approved, and distributed is daunting. Learn from a team of experts who have already achieved the successful launch and distribution of several life-saving vaccines.
Five Tips to Maximize the Value of Your Cell and Gene Therapy / ATMP
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In spite of this, CGT/ATMP holds great promise to deliver transformative outcomes for a wide range of traditionally hard-to-treat diseases.
Using Science to Navigate the Global Regulatory Maze
Achieving successful outcomes in a complex regulatory landscape can be challenging, especially when caught in the maze of regulatory requirements from varying agencies. For many pharmaceutical, biotech, and medical device companies, the objective is simply to reach the next regulatory milestones.