Turn Drug Development Theory into Actionable Strategy
The road from concept to first-in-human trials is filled with complex decisions. Understanding how CMC, clinical, and non-clinical aspects connect is critical—but theory alone won’t get your product to the next stage.
This hands-on workshop is designed to help you build a strong Target Product Profile (TPP) and define a Quality Target Product Profile (QTPP) for your drug development strategy. You’ll leave with a clearer path forward, armed with the tools, insights, to navigate developmental hurdles. During the workshop there is ample opportunity to gain advice from our senior trainers and discuss with your peers.
Agenda:
Introductions (10 min)
Theory (20 min)
- Overview of the pharmaceutical development process
- How CMC, clinical, and non-clinical elements intersect
- Learn the fundamentals of TPP, QTPP, and Drug Development Plans (DDP)
Practical exercise (120 min):
- Start creating your TPP & QTPP, customized to your product
- Identify and address key challenges in:
- drug substance scalability
- choice of formulation
Interactive Q&A/Discussion (30 min)
- Get answers to your specific challenges from senior experts
Build your TPP and take your drug development forward—register now! Limited spots available!
Trainers
Erik Gout, Director of CMC & CMC Senior Consultant
With a BSc in Analytical Chemistry, Erik joined Venn in 2020 as a CMC senior consultant and, in 2025, was promoted to director to lead our CMC department.
- 39 years of experience in the pharma industry
- CMC project manager and QA manager for start-ups, mid-sized and big pharma
- Experienced in technology transfers, regulatory documentation, GMP QA audits, and due diligence
- Knowledgeable and experience in development and GMP worldwide (EU, US, APAC, LATAM, BRICS)
Ronald Ullers, Regulatory Affairs CMC Senior Consultant
With a PhD in Molecular Microbiology from VU Amsterdam, Ronald joined Venn in 2015 as an RA-CMC consultant before becoming a senior consultant almost a year later.
- 16+ years of experience in regulatory affairs
- Expert in regulatory demands (focus on CMC) for global registrations of biological products, incl. recombinant proteins, vaccines, and ADCs
- Skilled in developing RA(-CMC) strategies, regulatory submissions, and liaising with US and EU agencies
- Authored scientific advice/Pre-IND briefing packages and served as Sponsor representative during advice procedures
