Hatch-Waxman and eDiscovery: Turbo-Charging Pharma Collections and Reviews

Presented by

Michael Sarlo, John Wilson, Albert Barsocchini, and Vazantha Meyers

About this talk

Navigating Hatch-Waxman legislation can be complex and challenging from legal, regulatory, and eDiscovery perspectives. The stakes are high for both brand name and generic pharmaceutical manufacturers as timing and ability to act swiftly in application submissions and responses many times mean the difference between market success or undesired outcomes. In this presentation, expert eDiscovery technologists and authorities will share information, insight, and proven best practices for planning and supporting time-sensitive pharmaceutical collections and reviews so Hatch-Waxman requirements are your ally and not your adversary on the road to legal and business success. Webcast Highlights + NDA and ANDA Processes Through the Lens of Hatch-Waxman + ECTD Filing Format Overview For FDA (NDA/ANDA Submissions) + Information Governance and Collections Under Hatch-Waxman + Dealing with Proprietary Data Types and Document Management Systems at Life Sciences Companies + Streamlining the Understanding of Specific Medical Abbreviations and Terminology + Best Practices and Proprietary Technology for Document Review in Pharmaceutical Litigation Presenting Experts + Michael Sarlo, EnCE, CBE, CCLO, RCA, CCPA - Michael is a Partner and Sr. EVP of eDiscovery and Digital Forensics for HaystackID. + John Wilson, ACE, AME, CBE - As CISO and President of Forensics at HaystackID, John is a certified forensic examiner, licensed private investigator, and infotech veteran with more than two decades of experience. + Albert Barsocchini, Esq. - As Director of Strategic Consulting for NightOwl Global, Albert brings more than 25 years of legal and technology experience in discovery, digital investigations, and compliance. + Vazantha Meyers, Esq. - As VP of Managed Review for HaystackID, Vazantha has extensive experience in advising and helping customers achieve their legal document review objectives.

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