Answers to the top eCTD v4.0 questions in 2024

Trevor Standish is a Product Director with over ten years of experience in creating and implementing innovative software products across various industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation. Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables. He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank Corp., where he demonstrated strong leadership skills, managed product portfolios, and defined strategic product roadmaps.

Maryanne is an accomplished, results-driven regulatory affairs professional specializing in eCTD submissions, FDA interactions, and project management. With 20+ years of experience, she has a proven track record of successful regulatory submissions to a variety of regulatory authorities.