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The European Chemicals Agency (ECHA) has proposed restrictions on the use of microplastics in products used in various market segments - including medicinal products. ECHA's broad definition of microplastics will result in a significant number of excipients falling into the scope of restriction along with increased labeling and reporting requirements for users. In addition, controlled release (CR) medicinal products have been targeted as sources of microplastics.
This webinar will review IPEC's intent to submit comments to ECHA and highlight issues that both users and makers can consider when submitting individual company responses.
Learning objectives for this webinar:
- description of microplastics
- review of ECHA’s restriction proposal and potential impact on the pharma industry
- reasons for the pharmaceutical industry to take immediate action by preparing and submitting constructive comments to ECHA
- discussion of inaccurate assumptions made by ECHA related to excipients and response strategy
Meera Raghuram is currently the Director, Regulatory Strategy and Policy for the Life Sciences Division of the Lubrizol Corporation. She has over 20 years of experience in complex technical and strategic regulatory issues related to pharmaceutical excipients, drugs/devices, environmental impact, risk assessments and liability management. She is a member of the IPEC Executive Board and serves as the Chair of the IPEC Regulatory Affairs Committee. She has also been involved in advocacy and leadership on critical environmental issues with various industry organizations including the American Chemistry Council and ASTM. Meera has a B.S degree in Pharmacy from the Indian Institute of Technology and a M.S. in Pharmaceutical Sciences from Purdue University, IN.