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We are delighted to welcome Despina Vasiliou, Innovaderm’s Regulatory Affairs Manager, who brings 8 years of industry experience. Known for her deep understanding of the regulatory landscape, Despina combines an analytical, scientific approach with strong organizational skills, making her an exceptional team leader.
Today, she will share valuable insights from the recent Regulatory Affairs Professionals Society (RAPS) Convergence 2024, held in Long Beach last September.
Artificial Intelligence
The most popular topic at the conference is artificial intelligence (AI). AI is a very big topic right now. Everyone is trying to see where AI fits into their everyday lives. However, after attending information sessions and talking to people one-on-one, a little bit of fear surrounding AI becomes evident. Questions arise about being replaced by AI and what roles will remain at the end of the day. These concerns are common and understandable.
AI can be a very intimidating topic, but insights from RAPS Convergence reveal that AI is not here to replace professionals; it is here to assist. Various systems and programs were showcased, particularly those supporting document creation and submission in regulatory affairs. For someone new to using AI for these tasks, the learning curve can be steep. However, AI has made significant advancement. Initially, systems could only handle a limited number of documents, but now they can process larger and more complex documents, including graphs and images, not just text. This capability is impressive and somewhat unexpected. In regulatory work, the primary concern remains the quality of these AI-generated documents.
The quality of the document is crucial. Discussions revealed that document outputs often contained errors; particularly sourcing errors where the origin of the text could be traced. Over the years, AI has improved, reducing these errors significantly. However, maintaining error-free documents necessitates a quality control step, which is unlikely to be removed. Regardless of AI advancements, human oversight remains essential for opening, reading, and identifying errors in documents. This cross-checking is vital in regulatory work to maintain high-quality standards. Overall, AI continues to grow and shows great potential. It is important to find a program or system that fits specific needs. Implementing an AI system can free up regulatory professionals for more strategic tasks, such as planning and decision-making, rather than just filling out application forms.
Unmet Medical Needs
A significant topic discussed was the unmet medical needs and the communication gap between drug developers and patients. There is a perception that pharmaceutical companies and patients, along with their caregivers, have differing views on the success of a drug. Typically, drug developers do not consult patients during the development process. Suggestions were made to enhance communication through patient advocacy conferences, face-to-face meetings, or by engaging with doctors and researchers to better understand patient needs. Communication is crucial in this context.
Conversely, patients often feel that regulatory authorities are too restrictive, hindering their access to drugs. One session highlighted the inclusion of women of childbearing potential or breastfeeding in clinical trials, which was a novel concept for many. Initially, this raised concerns, but the session, led by a regulatory authority representative, revealed a significant interest in including these women in trials, indicating thorough background work has been done on the matter.
The audience expressed skepticism, leading to numerous questions. One question raised was about the strong interest in including women of childbearing potential in trials, as it was believed that these women, especially if pregnant, would be reluctant to participate. However, information sessions and surveys indicated that women with rare diseases showed interest in participating in these trials. Effective communication remains crucial, requiring all stakeholders to come together and discuss the true needs of the industry.
Regulatory Authority Conversations
Regulatory authority conversations are a staple at these events. Sessions typically feature regulatory authorities providing updates on upcoming changes, recaps of the past year, and observed trends. New guidance or significant industry changes are often discussed. This year, there was a notable focus on medical devices, as well as the releasing of new guidance on the eSTAR platform by the US Food and Drug Administration (FDA), where they allowed attendees to ask questions directly. These sessions are particularly valuable because they offer a rare opportunity to engage with regulatory authorities in person, rather than through emails to general inboxes, putting them in the hot seat for direct questioning.
Solution Circles
A personal favorite of Despina are the solution circle sessions. Participation requires lining up, as only a maximum of 30 people are allowed and the lines are long. Despina had the opportunity to be included in 2 sessions during the RAPS Convergence. Solution circles are valued because they provide a space not just to listen but to share opinions and hear from people with diverse backgrounds. One session featured Despina as the sole CRO representative among sponsors, discussing the challenges sponsors face with CROs. She remained incognito, and took many notes, capturing feedback from various large and small sponsors, both from the US and Europe.
Another session focused on small clinics and their inspection challenges. Again, staying incognito, Despina took away from these conversations that communication is key. Clinics sometimes lack basic resources like printers, which can be surprising to larger CROs. Understanding their reality is crucial to providing effective support. Solution circles offer a unique learning opportunity to see problems from different perspectives and understand the day-to-day challenges other’s face.
Networking Opportunities
Overall, the conference offers excellent networking opportunities. Meeting people in hallways and information sessions often leads to engaging conversations. Initially, attending the first conference might feel intimidating, but everyone is welcoming and introduces themselves, coming from diverse backgrounds. This inclusivity ensures no one feels out of place, regardless of their knowledge level.
Chapter meet-and-greets are organized based on geographic areas, such as the Quebec chapter. These gatherings provide a chance to discuss local issues and participate in meetings, enhancing networking opportunities and expanding professional connections.
Another highlight is the “dine around” at the end of each day. A board on the main floor lists various dinner groups, allowing attendees to sign up and join others for dinner. This setup facilitates meeting new people and enjoying meals together, making it a favorite aspect of the conference.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
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