information about this regulatory seminar

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:
2014.5.6(Taipei), 2014.5.7(Kaohsiung)
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
IV. Agenda:
Check in
Welcome Note
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?
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?
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
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: