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.
How to Face Compliance Challenges in a Regulated Environment
There’s no question that complying with pharmaceutical, biotech and medical device rules and regulations costs money. In addition to the expenses for hiring and retaining qualified compliance professionals, companies also incur expenses related to implementing and enforcing procedures designed to achieve compliance. In this training workshop, learn the true cost of non-compliance, based on real events that have taken place at pharmaceutical companies and manufacturing facilities. We’ll also take a look at FDA enforcement trends.
July 21, 11am ET / 5pm CET
Effective FDA Engagement
FDA faces challenges and new review models that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy continue while effective regulator engagement stays critical. This webinar will explore topics of effective FDA engagement, best engagement practices, and what is the right engagement level.
September 22, 11am ET / 5pm CET
Regulatory CMC Pitfalls US vs. EU
Registration opens soon
September 15, 11am ET / 5pm CET
How to Face Compliance Challenges in a Regulated Environment #2
Registration opens soon
September 29, 11am ET / 5pm CET
Vigilance in Medical Device
Registration opens soon
October 6, 11am ET / 5pm CET
Past Webinars – On Demand
Tips From Qualified Persons (QPs) for Successful Importation and Commercialization, and Clinical Trials in EEA/UK
Accessing new markets for exporting pharmaceutical and biotech products or conducting clinical trials in Europe can be a challenge. There are many complexities that can impede your efficiency to market and attainment of your commercial goals such as establishing a legal entity with a QP in the region, and passing inspections to secure your own Manufacturing & Importation Authorization (MIA) license. How can you prepare to bring your products to market successfully
The Journey of ATMPs From the Discovery to Routine GMP Real Life
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, ATMP holds great promise to deliver transformative outcomes for a wide range of traditionally hard-to-treat diseases. Learn how you can accelerate your CGT product development and how to manage the everyday challenges with a commercial ATMP.
A Statistically Leveraged Dose Escalation Study Design (BOIN)
Determining the recommended phase 2 dose of a study drug is a critical step in the life cycle of a clinical drug’s development. The Bayesian Optimal Interval Design (BOIN) design improves upon both of these items while also facilitating quick and simple decisions regarding escalation, de-escalation or maintaining the current study dose. How can we design our dose escalation studies to identify the recommended phase 2 dose in a more efficient way?
To Decentralize or Not Decentralize … That is the Question
It’s no secret the pandemic caused trial delays, loss of patient participation and loss of critical trial data needed to get products to market. Not all studies, visits, or procedures are a good fit for DCT, so it’s important to design your protocol with decentralized visits in mind, considering both the patient and site perspective. Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity.
AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
The 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.
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?