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he European Chemicals Agency (ECHA) is moving forward with proposed restrictions on the use of microplastics in products used in various market segments – including medicinal products. ECHA’s broad definition of microplastics may impact many excipients and drug products leading to increased labeling and reporting requirements. Based on current information, it is feasible that the regulation will come into force in late 2021 or early 2022.
Excipient manufacturers will need solubility and biodegradability data to confirm whether their excipients meet the definition of microplastics or not. Data will also be required to justify derogation of polymers that are permanently modified and no longer meet the definition of microplastics in end use applications. Materials that meet the definition and are derogated based on the intended use will still require labeling as microplastics. Even though medicinal products and food are derogated, there will be reporting obligations for pharmaceutical and food which include reporting quantity of microplastics released to the environment, either estimated or measured in the previous year.
All this will require strategy, collaboration and consistency; and the industry sector (excipient manufacturers and drug product manufacturers) will need to work together and coordinate efforts. Note that ECHA has stated that reporting requirements will continue until microplastics are no longer used. This implies reformulation may be needed - which is not an optimal or a justified approach for medicinal products.
Additionally, the webinar will also discuss what industry can do in the long term to collect credible data and evaluate longer term strategy for medicinal products.
Attendees will be provided with:
- An overview and description of microplastics
- A review of ECHA's restriction proposal and potential impact on the pharma industry
- Data requirements for excipients that are “out of scope for microplastics restriction” and derogations for excipients that are permanently changed and no longer microplastics in end use
- A collaborative strategy to address data issues
- A discussion of industry efforts to develop better emissions estimates
- Discussions about what medicinal products and related industries can do in the longer term to collect robust data and possibly advocate for future changes to the regulatory landscape
Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; Vice President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.
Ms. Priscilla Zawislak has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products. She is IPEC-Americas Immediate Past-Chair and is the current Vice President of the IPEC Federation. Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business. Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).
Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee. She is also Vice President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.
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 IPEC-Americas Executive Committee and serves as the Chair of the IPEC-Americas 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.