BUSINESS WIRE: Shelley Gandhi Joins Firm – Headlines ELIQUENT’s Expanded Pharmacovigilance Service Offerings

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WASHINGTON --(BUSINESS WIRE)-- 04.11.2024 --

ELIQUENT Life Sciences (ELIQUENT), a global regulatory consulting firm, today announced that internationally recognized pharmacovigilance (PV) expert Shelley Gandhi has joined the firm. This strategic addition to ELIQUENT’s robust team of regulatory and quality leaders reinforces the firm’s commitment to delivering integrated solutions that streamline compliance, manage risk, and accelerate time-to-market.

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“Shelley’s firsthand knowledge of regulatory expectations and her proficiency in navigating complex regulatory challenges will be instrumental in expanding ELIQUENT’s pharmacovigilance solutions to meet the growing global demand for comprehensive safety and risk management across diverse markets,” said Tim Dietlin, Chief Executive Officer, ELIQUENT Life Sciences.

Global Pharmacovigilance Expertise

Shelley Gandhi brings more than three decades of global PV and risk management experience to her role at ELIQUENT. Her extensive professional background includes more than 19 years of service at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). During her tenure, Shelley served in multiple senior positions where she gained extensive knowledge of all European regulatory processes relating to monitoring the safety of licensed medicinal products and ancillary devices.

Shelley’s distinguished MHRA career included a role as the UK representative on the European Medicines Agency’s (EMA) EudraVigilance Expert Working Group. In this capacity, Shelley was instrumental in shaping EMA’s system for managing and analyzing information on suspected adverse reactions to medicines. Her contributions further enhanced key PV processes and systems across Europe.

Prior to joining ELIQUENT, Shelley served for more than 12 years as a strategic PV advisor to clients building and managing risk management systems. Shelley provided support to biotechnology clients across a broad range of therapeutic areas. Her experience includes strategic and technical advisory services in multiple markets from early clinical development to launch readiness.

At ELIQUENT, Shelley works with clients to ensure compliance with global safety standards, while anticipating changes, and preparing proactive solutions. Her deep understanding of drug safety and risk management protocols, coupled with her regulatory and industry experiences, amplifies ELIQUENT’s expanded PV and Risk Management Solutions. Learn more about Shelley.

Pharmacovigilance & Post-Market Surveillance Solutions

ELIQUENT’s expanded PV and Risk Management Solutions optimize practices to ensure consistency, compliance and operational efficiency across diverse markets. With decades of experience developed as leaders in both the public and private sectors, ELIQUENT’s industry-recognized PV experts support innovators with precision and expertise - enabling clients to confidently navigate global post-marketing surveillance, adverse event reporting, and risk management planning. Because there is no one-size-fits-all approach, each solution is built to support regulatory objectives, while aligning with evolving global demands. ELIQUENT’s customized global Pharmacovigilance & Risk Management Solutions include:

• Global Support: Trusted guidance when navigating and complying with global PV regulations
• Adverse Event Reporting: Systematic identification, objective analysis, and strategic guidance responding to unintended occurrences
• Regulatory Reporting: Technical skill and institutional knowledge of complex regulatory reporting obligations
• Signal Detection: Expert development and implementation of detection processes, including reporting and risk communication
• Risk Assessment & Management: Proactive identification, assessment and planning to manage potential risk and ensure regulatory compliance
• Post-Marketing Surveillance: Established network experts to support commercial product safety systems and reporting function
• Risk Communications: Strategic development of communications plans to address emerging safety concerns and instill confidence in the market
• Clinical Trials Safety Oversight: On-demand resources to support safety monitoring before and after regulatory approval
• Qualified Person for Pharmacovigilance (QPPV): Comprehensive QPPV solutions ensure clients meet EU, UK, and regional pharmacovigilance requirements, while safeguarding patient safety.
• Global PV Training: Bespoke pharmacovigilance training programs to uphold the highest regulatory standards across diverse global markets.

Integrated Solutions – Full-Service Support

ELIQUENT redefines regulatory consulting with a full-service platform that delivers integrated solutions across the product lifecycle. The firm's unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to advise clients on the complex process of bringing new therapies to market and manufacturing them to quality standards. ELIQUENT's integrated platform of regulatory solutions feature the following integrated service offerings:

• Regulatory Affairs Solutions: From the earliest phases of innovation through regulatory submissions, to post- approval support, ELIQUENT guides companies to approval and beyond.
• Pharmacovigilance & Risk Management Solutions: With an approach that includes both strategic direction and hands-on global support, customized PV solutions empower companies to operate with confidence.
• Quality & Compliance Solutions: Highly specialized compliance experts build customized solutions that equip companies with best- in-class strategic support, technical expertise, and project-based solutions.
• Remediations Solutions: Respected professionals and global experts bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to remediation solutions.
• Talent Solutions: Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives clients the ability to rapidly scale teams to the right size, with the right level of expertise, in the right locations.

About ELIQUENT Life Sciences

ELIQUENT Life Sciences is the fusion of six global regulatory consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, RApport Global, and IDEC. ­­ELIQUENT team works cross-functionally to deliver the global solutions that pharmaceutical, biotechnology, and medical device companies need to gain and maintain authorization for the products. ELIQUENT’s comprehensive services support innovators across therapeutic modalities, phase-based pathways, and major global markets. ELIQUENT’s continued growth is supported by GHO Capital, the European specialist investor in healthcare.

Learn more about ELIQUENT Life Sciences at eliquent.com.

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Taryn Fritz Walpole
twalpole@eliquent.com