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Regulatory Business

Pre-Conference Workshop: Start-Ups: Effective Use of the Money of Your Investors - Know What to Aim For

Monday, May 6, 2024
08:30 – 16:00 CEST
Location: A 05
Ticketed Event Learning Level: Intermediate
Starting a company in the MedTech or the Pharma industry is a significant undertaking. Securing investment is the most critical challenge for any startup, however, understanding the regulatory requirements for pharmaceutical and medical devices and utilizing the regulatory pathway to optimize spending, can make the difference between success and failure in bringing the innovation to the market.

Navigating the intricate maze of regulatory requirements is a complex and daunting challenge. Engaging with regulatory agencies and understanding the regulatory pathways available for approval allows optimizing spending, achieving critical milestones, increasing the valuation of the startup, and securing further investment. The Workshop will equip you with insider tips on how to develop a smart regulatory pathway.

Building robust QA/QMS systems and ensuring compliance with GMP/ISO standards is essential for regulatory approval of Pharma/MedTech products. Compliance with adequate documentation is a must. Experts will present how to timely phase-in compliance with these requirements and will present examples of smart tools that can facilitate implementation.

Building a strong team with adequate RA and QA expertise is also key to bringing a startup to the market but is regularly in conflict with financial resources. Therefore, determining when to hire full-time employees and when to engage with third party experts to fill knowledge gas needs to be evaluated all along the product development and regulatory pathway as this will contribute to optimizing spending.

Most founders need to understand those aspects well before raising significant funds. While the majority of this workshop will be about developing and executing a smart regulatory pathway, it will also discuss important aspects to consider during or in preparation for fundraising.

Who Should Attend: Pharmaceutical and Medical Device startup founders, regulatory affairs professionals, investors and anyone involved in product development and compliance.