Anacura

Lab visit + key note speaker on biologics

09/06/2016
15:00 - 19:00

Anabiotec & RIC proudly invite you to their workshop on insights in the regulatory requirements for biologics

 

 

UPLC_Waters_1

Analytical Expectations for Biotech / Biosimilar Products: What Is Needed, When, and Why

Speaker: Nadine M. Ritter, Ph.D. - President and Principal Advisor, Global Biotech Experts, LLC

You have the opportunity to visit our labs:

Lab tour 1: 15-16h   Lab tour 2: 17-18h

Networking reception as from 17h

Nadine Ritter

Nadine Ritter has been an international consultant for biotech and biosimilar products since 2002. Throughout her career, she has contributed to the success of over twenty 510(k)/PMA, fifty IND/IMPD and fifteen NDA/BLA/MAA filings. She has engaged in numerous PAI readiness audits and due diligence inspections, and has remediated analytical, regulatory and

laboratory compliance problems. Recently, she contributed CMC analytical and stability expertise to two approved breakthrough products in the US, three approved biosimilar products in the EU, and two in the US. In 2003, she was one of six industry and two FDA founders of the CaSSS CMC Strategy Forum. Before she worked as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). Later, she became the Director of the Analytical Services Division of BioReliance (Rockville, MD). She lead a team of CMC scientists, responsible for product characterization and comparability studies, method development & validation, QC release and stability testing and managed quality and compliance activities for the R&D, GLP and GMP activities. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles.

 

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