The EU legislation workshop for cosmetic products and medical devices I. Background: International trade is one of Taiwan's economic mainstream. With the gradual recovery of the global economy and the government will revive the export trade as a major goal on economic revitalization. The cosmetics and medical devices are competitive exporting items in Taiwan. At the mean time, the EU is a very good export market. Due to the CPNP of EU has issued many new regulations for food, cosmetic products and medical devices products since 2012. In order to help the industry have better understanding on the regulations for exporting to EU., we had invited our Regulatory Services Partner in EU -- CE.Way Regulatory Consultants Ltd. come to Taiwan to share these regulations for cosmetics and medical devices. II. Organizers: Organizer: CE.Way Regulatory Consultants Ltd. and Sinew Consulting Group Ltd. Co-organizer: Nankang Biotech Incubation Center and Kaohsiung Medical University III. Seminar: Date: 2014.5.6(Taipei), 2014.5.7(Kaohsiung) Time: 9:30-12:00 am Place：Nankang Biotech Incubation Center (17F., No.3, Park St., Nangang Dist., Taipei City) Kaohsiung Medical University (100, Shih-Chuan 1st Road, Kaohsiung City) IV. Agenda: Time 9:00-9:30 9:30-9:40 9:40-10:30 10:30~10:40 10:40~11:30 Subject Presenter Check in Organizer Welcome Note Organizer The EU legislations on Mr. Tadej Feregotto cosmetic products – which (in English) requirements do you have Dr. Newton Yau to fulfill in order to be (in Chinese) able to sell in the EU? Break The EU legislations on Ms. Sonja Bobnar medical devices– which (in English) requirements do you have Dr. Newton Yau to fulfill in order to be (in Chinese) able to sell in the EU? 11:30~12:00 Q&A Mr. Tadej Ms. Sonja Bobnar Dr. Newton Yau *1 Ms. Sandra Huang*2 V. Speakers Brief: Mr. Tadej Feregotto：： CE.way Regulatory Consultants Ltd. (Ireland) – CEO and cosmetics regulatory consultant – In charge of notification and regulatory consulting to cosmetic companies. Was cosmetics EU regulatory consultant at Obelis Master of economics University of Southern Denmark, Denmark Faculty of Economics University of Ljubljana, Slovenia Ms. Sonja Bobnar 2012 – currently Dr. M. Burstein d.o.o., Slovenia – Managing director, cosmetics regulatory consultant, medical device consultant, trade mark consultant. 2010 – 2012 BMS inženiring d.o.o., Slovenia – Cosmetic products importer and distributor, responsible for regulatory compliance of products imported in community. 2010 – 2012 Proloco Medico d.o.o., Slovenia – Administrator for medical products, working closely with insurance offices, charging medical devices to insurance offices for insured patients M.Sc. in Management in tourism organizations 2009 - University of Primorska, Faculty of Tourism, Portorož Dr. Newton Yau, Cheif Consultant *1 Responsible for international cooperation Ms. Sandra Huang, Executive Consultant *2 TFDA Qualified Regulation Advisor for Medical Products Responsible for the regulations services VI. Registration Fee: Free