ERM Webinar: Medical Regulatory Insights And Business Shifts in Taiwan

Dr. James Leu is a Senior Partner of ERM Taiwan and regional Leader for Central East Asia Product Stewardship with more than 25 years of EHS consulting experience. Dr. Leu has directed and managed numerous Phase I and II environmental site assessment, environmental health and safety (EHS) management system and corporate audit programs, EHS due diligence, environmental & social due diligence, product stewardship & chemical registration, site investigation and remediation, waste management, environmental permitting, EHS monitoring and regulatory compliance assessments for both local and multi-national corporations. He has directed, managed and conducted over 1,000 EHS and product stewardship related consulting projects in Taiwan, China, Thailand, Vietnam and the Philippines.

Jill is one of the partners heading Lee & Li's Healthcare and Life Science Practice Group. She has been an attorney in Taiwan for more than 20 years and she has been working at Lee & Li for more than 15 years. Since she joined Lee & Li in 2001, she has been advising for many of the firm's healthcare/life science industry clients on various types of matters including product registration and regulatory compliance, clinical trials, activities of sales, marketing and promotion of healthcare products, interactions with HCPs/patient groups and privacy/data protection issues.

Jill also has extensive experience in assisting local chain medical centers in establishing SOPs for risk management and in negotiations and mediations on malpractice claims and other claims in connection with medical services and counselling local association with respect to the code of marketing practices and the procedure of mediation on disputes over the compliance thereof.

Katherine is an associate partner at Lee & Li's Corporate and Investment Department and is a core member of the Healthcare & Life Sciences practice group. Katherine has substantial experience in providing comprehensive legal services to clients from the health and life science sector. She has been providing legal consultation on risk management and compliance regarding transactions and interaction with health care providers, regulatory matters, data protection, promotional activities, general code of conduct, and has assisted clients in negotiation and remedy in reimbursement price disputes.

She has also represented many multinational pharmaceutical companies in patent litigation, unfair competition claims, IP collaboration and licensing negotiations, and patent term extension disputes. In addition, Katherine also advises on product liability issues, including the pre-marketing and post-marketing legal compliance, product recalls and other product regulatory issues in Taiwan.

Clare is a Senior consultant based in ERM Taiwan with over 11 years in medical products regulation experience prior to join ERM. Major in pharmaceutical regulation including NDA/ANDA registration, PMF registration/ site audit, any kind of variation, and license maintenance. Also familiar with medical device, food, cosmetic, and electronic product regulations. She has successfully handled regulatory cross-function project and registered many medical products.

Clare is a strong support and a solution maker for business department or clients to solve business/ supply/ import/ hospital listing/ regulation problems. For the reviewing and licenses handling experience, she has reviewed over thousands of whole technical dossiers for pharmaceutical products. Furthermore, she has successfully handled and maintained hundreds API GMP certificates, product licenses, and Drug master files (DMFs).