Upcoming Event
Mastering the EU CTR: How to Adapt and Succeed Under the New Framework
October 21 , 2025
Webinar
12:00 pm - 1:00 pm ET
About Webinar
A focused session designed to equip clinical trial professionals with the strategies and practical insights needed to thrive under the new regulation. Our speakers will break down the key provisions, highlight common challenges, and share best practices for efficient trial design, submission, and execution in the EU.
What You'll Learn:
- Key differences between the EU CTR and previous directives
- Practical steps to ensure compliance across the trial lifecycle
- Strategies for streamlining submissions through the Clinical Trials Information System (CTIS)
- How to anticipate regulatory scrutiny and avoid common pitfalls
- Real-world insights from organizations successfully adapting to the EU CTR
About Speaker
Jay Russak, MBA
Jay Russak is a seasoned clinical development leader with more than 18 years of experience guiding drug development programs across all phases of clinical trials. He holds dual science degrees and an MBA, bringing a balance of technical expertise and business acumen to advancing complex clinical programs. Jay has held increasing leadership roles in biotech companies, including but not limited to Biogen, Sage Therapeutics, Dicerna, and most recently Keros Therapeutics. In addition to his industry career, he serves as an adjunct lecturer at Northeastern University, where he teaches graduate courses on drug, biologic, and device regulations, sharing practical insights with the next generation of clinical research professionals.
About the Webinar
A focused session designed to equip clinical trial professionals with the strategies and practical insights needed to thrive under the new regulation. Our speakers will break down the key provisions, highlight common challenges, and share best practices for efficient trial design, submission, and execution in the EU.
What You'll Learn:
- Key differences between the EU CTR and previous directives
- Practical steps to ensure compliance across the trial lifecycle
- Strategies for streamlining submissions through the Clinical Trials
Information System (CTIS) - How to anticipate regulatory scrutiny and avoid common pitfalls
- Real-world insights from organizations successfully adapting to the EU CTR
Meet the Speaker:
Jay Russak, MBA
Jay Russak is a seasoned clinical development leader with more than 18 years of experience guiding drug development programs across all phases of clinical trials. He holds dual science degrees and an MBA, bringing a balance of technical expertise and business acumen to advancing complex clinical programs. Jay has held increasing leadership roles in biotech companies, including but not limited to Biogen, Sage Therapeutics, Dicerna, and most recently Keros Therapeutics. In addition to his industry career, he serves as an adjunct lecturer at Northeastern University, where he teaches graduate courses on drug, biologic, and device regulations, sharing practical insights with the next generation of clinical research professionals.
Upcoming Event
Mastering the EU CTR: How to Adapt and Succeed Under the New Frame
September 24th , 2025
Webinar
12:00 pm - 1:00 pm EST
(This is a private event)
Agenda
- 6:00 – 7:00 PM
- Arrival, Cocktails & Networking
- 7:00 – 7:15 PM
- Dinner Begins & Welcome Introductions
- 7:15 – 7:45 PM
- Presentation: European Data Privacy Roadmap – Key Considerations to Ensure Privacy Compliance in Europe
- 7:45 – 8:15 PM
- Dinner – Main Course Service
- 8:15 – 8:45 PM
- Case Studies: Clin Ops Solutions – Sponsor Challenges in Practice
- 8:45 – 9:00 PM
- Q&A and Open Discussion
- 9:00 PM
- Wrap-Up & Departure
Upcoming Events
Upcoming Events
Evolution Summit
March 11-13, 2025
San Francisco, CA
Join Us at the Precision in Clinical Trials Summit on April 28-29 in Boston. The conference website is: Precision In Clinical Trials Summit | 28-29 April 2025 - Boston
Upcoming Events
2025
Diversity in Clinical Trials
Community and Clinical Research Connected
Get ready to be apart of an electrifying conversation with industry leaders and community stakeholders as we dive into the vital topic of diversity in clinical trials! Join us for an in-depth exploration of best practices, innovative recruitment strategies, how to effectively collaborate, and more.
Don’t miss out on this dynamic discussion!
30-January
Conference Center at Waltham Woods | Waltham, MA
8:00 AM - 12:00 PM EST
Free Event
(Breakfast included)
Co-Host
