(Westbury, NY— November 2019) Two top FDA and industry experts from Lachman Consultant Services, Inc., (“Lachman Consultants”) will be participating as panelists at The Association for Accessible Medicines (AAM) Generic (GRx) and Biosimilar (Biosims) Conference, also known as AAM GRx+Biosims, on November 4-6, 2019, at the Bethesda North Marriott Hotel & Conference Center in Bethesda, Maryland. With broad expertise and regulatory experience in the development, review, and approval of drugs and devices, Lachman Consultants employs many former FDA and industry experts who provide superior advisement in regulatory affairs. Lachman Consultants is a Gold Sponsor of the GRx+Biosims conference.
Aloka Srinivasan, PhD, and VP, Regulatory Practice, will be moderating the panel on “Drug Substance and Drug Product Manufacturers—Partnering to Improve the Process” on Day 1 of the conference. The panel discussion will explore common challenges and deficiencies in the quality, submission, and review of drug master files (DMFs) and ways to address them to ensure approvals of abbreviated new drug applications (ANDAs) meet Generic Drug User Fee Act (GDUFA) goals.
Robert Pollock, MS, Senior Advisor, Outside Director to the Board, will be a panelist on “Controlled Correspondence: The Evolution and Opportunity” on Day 2 of the conference, where the focus will be a discussion of the Controlled Correspondence submission process, which over time has become more structured and efficient, yet increasingly more complex.
“We welcome the opportunity to have a role at GRx+Biosims, where we have the ability to educate others about our deep knowledge of complex compliance requirements, not just in the U.S. but also globally,” said Pollock. “At GRx+Biosims, we also have many opportunities to heighten our own knowledge and awareness of the continually changing world of pharmaceuticals, biotechnology, and biologics.”
Be sure to visit the Lachman Consultants team who will be attending GRx+Biosims 2019 to gain more insights into the company’s capabilities and services.
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ABOUT AAM GRx & BIOSIMS 2019
GRx+Biosims 2019 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory, policy and legal professionals. Top officials and subject matter experts share their knowledge and best practices to help attendees understand how to succeed in generic and biosimilar development, the regulatory process, approvals and the evolving policy landscape.
ABOUT LACHMAN CONSULTANTS
Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device, and Related Life Science Industries. Lachman Consultants deliver highly effective and proven solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, and Training, which have been shown to consistently exceed client requirements and expectations.