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MEET THE EXPERT PROGRAMME
In partnership with the Korea Pharmaceutical Traders Association, “Meet the Expert” slots are provided to international pharmaceutical companies wishing to understand the specifications of the Korean market and get hands-on advice on how to register their products via a free 30 minute slot.
If you wish to apply for your slot, please fill in below and return it to Ms. Kahyun Kim ([email protected]) no later than Aug 10th. Please also note that slots are attributed on a first come first served basis and these can run out before the deadline.
We really thought the “Meet the Expert” program was a valuable addition to CPhI Korea. We found the expert we spoke with very knowledgeable and he was able to provide us with a lot of hands on information on the Korean regulatory landscape. The fact that this was a “one on one” session meant that we could raise all our points. ~ Marieke Van Dalen, Board Member of APIC
The free « Meet the Expert » one to one 30 minutes session was a unique opportunity for Pharmatoka to better understand the requirements of the local health authorities for the registration of our herbal medicines. Our questions were sent to the Experts several weeks before the meeting and the answers were well prepared. The Expert’s knowledge and expertise raised all our doubts and Pharmatoka is confident that together with our new partner, patients will be able to benefit our herbal medicines in South Korea in the near future. ~ Gunter Haesaerts, CEA, Pharmatoka SAS
Please provide the information in the fields below as detailed as possible and the experts will select the applicants
based on the information. The applicants will be notified about the application status via e-mail before August 20th.
Submission: Ms. Kahyun Kim ([email protected]). Please note that the application itself does not guarantee the
acceptance into the programme.
■ Company Information
Company
Salutation ☐Mr. ☐Ms. ☐Dr. First name Last Name
Position Department
Address Country
Website E-mail
Telephone Mobile
Business Type ☐ Importer ☐ Distributor ☐ Manufacturer ☐ Licensor ☐ Others
Please attach the below documents along with the application
☐ Flight E-ticket (Due: August 10th) ☐ Business Card (Name Card) ☐ Company Brochure ☐ Passport Copy
Application
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CPhI/ ICSE/ P-MEC/ BioPh/ Hi Korea 2019 Secretariat
Tel. +82-2-6715-5400 ㅣ Fax. +82-2-432-5885
8F. Woodo Bldg., Manguro 214, Jungrang-gu, Seoul, Korea (02121)
▼ Please kindly tick appropriate product category(ies) and briefly describe products belonging to each category that
you would like to consult the experts on.
Product Category
☐ APIs
☐ Generic APIs
☐ Custom Manufacturing
☐ Fine Chemicals and Intermediates
☐ Excipients
☐ Technology, Laboratory and Analytical Equipment
☐ Biopharmaceuticals
☐ Pharmaceutical Packaging
☐ Natural Extracts
☐ Contract Services
☐ Pre Clinical Trials, CRO, Clinical Data
☐ Medical Devices
☐ Medical Technologies
☐ Others
Product Category Detailed Products
Country of production Qualifications/Approval Current relationship with Korean market
Questions to the Experts
▼ Please use the extra table below if you have more than one product category to consult on.
Product Category Detailed Products
Country of production Qualifications/Approval Current relationship with Korean market
Questions to the Experts
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CPhI/ ICSE/ P-MEC/ BioPh/ Hi Korea 2019 Secretariat
Tel. +82-2-6715-5400 ㅣ Fax. +82-2-432-5885
8F. Woodo Bldg., Manguro 214, Jungrang-gu, Seoul, Korea (02121)
■ The Experts
Please indicate the expert with whom you would like to consult with by ticking a box. The experts will review
the information and confirm once all the applications have been submitted.
A.
Tae Moo Yoo
F&D Consulting Group
CEO
✓
Establishment of drug development strategy
Consultation of pharmaceutical regulation of Korea
Consultation of clinical trial application of Korea
Consultation of pharmaceutical marketing
authorization(approval) of Korea Preparation of CTD of pharmaceutical product Rearview of CMC, toxicology, pharmacology, and -clinical trial data
Preparation of scientific evidence as supportive data for the drug approval
B.
Young-Eun Kim
Synex Consulting Ltd.
RA Director of Pharmaceutical Affairs
✓
Industry experiences include drug developments in Samsung Medical Center and Start up biotech company
Consultation of regulatory affairs of pharmaceuticals (Chemicals, Biologics)
Import products’ registrations and regulatory strategy
Regulatory filing to address requirements based on Korea regulations
Consultation of DMF, ODD, NDA, paper-NDA, IND, Feasibility / gap analysis, MFDS
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CPhI/ ICSE/ P-MEC/ BioPh/ Hi Korea 2019 Secretariat
Tel. +82-2-6715-5400 ㅣ Fax. +82-2-432-5885
8F. Woodo Bldg., Manguro 214, Jungrang-gu, Seoul, Korea (02121)
■Meeting Details
Please indicate all of your time availability by ticking as many time slots as possible. The experts will review the
information and confirm one slot out of all availabilities selected. Kindly note that slots may not be available if
all the slots are fully booked.
Slot 22 Aug ✓ A/B-1 14:00 - 14:30 ☐
A/B-2 14:40 - 15:10 ☐
A/B-3 15:20 - 15:50 ☐
☐ I will commit the meeting on time. Should there be any changes needed to the pre-arranged slot, I will notify
Ms. Kahyun Kim ([email protected]) no later than August 15th, 2019.
Applicant Mobile Number Signature
■ Enquiries
CPhI/ ICSE/ P-MEC/ BioPh/ FDF/ Hi Korea 2019 Secretariat
Contact: Ms. Kahyun Kim ([email protected], Tel. +82-2-6715-5421)
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