Meet Adnovate Clinical at Bio-Europe Spring in Barcelona. March 18-20, 2024.

JP Morgan is the largest and most informative healthcare investment symposium in the industry. The conference connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

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From GCP to GVP Whitepaper: A Pharmacovigilance Guide for Emerging Biotech Firms Transitioning from clinical development to post-marketing represents a critical phase for emerging biotech companies, demanding the establishment of robust pharmacovigilance (PV) systems. Given the resource and expertise constraints often faced by smaller biotech firms, outsourcing to Contract Research Organizations (CROs) emerges as a viable solution. However, this approach introduces its own set of challenges, including maintaining control, ensuring quality, and managing flexibility. This whitepaper explores strategic considerations and practical steps to optimize PV activities outsourcing. It aims to guide biotech executives through the challenges of selecting operating models that align with their company’s objectives, regulatory demands, and market dynamics. The paper discusses the balance between leveraging external expertise and retaining crucial oversight of PV operations.