Questions regarding the Regulatory Process? Join us for an insightful session with bwtech EiR experts Fehmida Kapadia and Richard Chipkin!

Agenda: May 14, 2025

• Networking and Lunch 11:30 AM – 12:00 PM
• Presentation 12:00 PM – 1:00 PM
• Q&A and Networking 1:00 PM – 1:30 PM

REGISTER Today!

Understanding the Regulatory Process: Tips and Tools for Success

• Building a regulatory strategy for successful product development
• Navigating the FDA regulatory landscape
• Essential tools to enhance your regulatory strategy
• Practical tips for streamlining your regulatory compliance

Tips for Navigating Industry Regulations

• Start Early: Engage with FDA early (during pre-clinical stage) and often.
• Stay informed: Regularly review updates to regulations in your industry
• Develop a compliance strategy: Create a systematic approach to meet regulatory requirements
• Invest in training: Ensure your team is well-versed in relevant regulations
• Leverage technology: Utilize compliance management software to streamline processes
• Seek expert advice: Consult with regulatory specialists or legal counsel when needed
• Document everything: Maintain detailed records of your compliance efforts
• Conduct regular audits: Periodically assess your compliance to identify areas for improvement

About Fehmida Kapadia

Fehmida Kapadia is a seasoned expert in entrepreneurship, business strategy, and innovation. As Founder and President of Kapamed Consulting, she guides inventors, founders, and startups through technology commercialization, offering strategic insights to help them build and scale. With 19 years of experience, Fehmida has supported nearly 100 entrepreneurial ventures in roles spanning consulting, mentorship, and education. She has taught technology entrepreneurship at Case Western Reserve University and was a Fulbright scholar in Brazil. She also mentors startups through the Maryland Tech Council and Johns Hopkins Technology Ventures and serves as Membership Vice Co-Chair for Women in Bio’s Capital Chapter. Holding a PhD in Biochemistry from The Ohio State University and a master’s in Biotechnology Entrepreneurship from Case Western Reserve, Fehmida specializes in strategy, fundraising, partnerships, and biomedical product development. At bwtech, Fehmida continues to shape the entrepreneurial ecosystem, helping startups thrive.

About Richard Chipkin

Dr. Richard Chipkin has over 40 years of experience in biotech and pharmaceuticals, specializing in drug development, business strategy, and entrepreneurship. As President/CEO of Psyadon Pharmaceuticals, he secured $15 million in funding and led the development of Ecopipam, a first-in-class Tourette Syndrome treatment now in Phase 3 trials. Previously, as President/CEO of Psychiatric Genomics, he raised $25 million in venture funding and secured key academic licensing agreements. His tenure at Merck/Schering-Plough included negotiating major product licenses, such as INTEGRILIN®, which surpassed $250 million in sales. A neuropharmacology expert with 70+ publications and six patents, Rick holds a PhD in Pharmacology from the Medical College of Virginia. As an Entrepreneur in Residence at bwtech, he mentors startups on funding, regulatory affairs, and go-to-market strategies, helping them turn innovation into commercial success.

Don’t miss this opportunity to optimize your regulatory approach! Space is limited, so reserve your spot today!