연사: Lee Tyalor

 Q1

 How handle Due Deliquence for newly industrialized centuries?

 Due Diligence 

The state of the Company or the Country that it is head quartered within should not distract you from following a clear & formal due diligence path.

Once your Quality Manager/Audit team have performed a clinical / manufacturer etc audit and your commercial finance teams have scrutinised terms, partner fiscal risk, and risk of return on your Capital then some results will be presented to you.

At that point when you have full facts, you may then take a view that a Company is less well equipped due to Country development status. If the risk is identifiable, modest & manageable and the potential value of the deal is attractive for you, then due diligence has done its job (to identify risk) and the decision is yours to move forwards or not. 

 Q2

 What is NPV approximately as robust BD process?

 NPV & the BD process 

When you are selling a product, the first thing to understand is whom you are selling the product to. 

The Net Present Value of a product estimates the life time cost and revenues of the product and accordingly calculates a value. As the product matures it may, for example, complete a Regulatory milestone. At this point in time the asset is theoretically closer to revenue than it was. As such a NPV is good for the period of time and the assumptions that calculated it. After major assumption changes the NPV goes up or down according to events. 

So. If your product NPV calculates to +$50m then it’s unlikely that you should try to approach a large pharmaceutical company with it. This is because a large company would probably not License-in a product with a $50m NPV as the revenue potential from a product like this would not make commercial sense. 

Accordingly, if your BD team tell you that they are going to approach Pfizer, JnJ, Novartis etc with a $50m NPV product then you may wish to consider their judgement and their understanding of pharmaceutical business development. 

 연사: Edson Brito

 Q1

 Are there any websites or public sites where I can get information about the Brazilian pharmaceutical industry and companies?

 There are many, however you need to mining them.. I will write some of them during the presentation for your reference Grace. btw.. Do you speak Portuguese?
https://www.ictq.com.br/
www.datasus.gov.br
www.anvisa.gov.br
www.saude.gov.br
www.pfarma.com.br
www.sindusfarma.org.br
https://www.interfarma.org.br/
http://www.pharmanet.com.br/ 

 연사: Xuemei Sun

 Q1

After acquisition of market authorization through licensing business how often inspect launched products regarding PMS? 

 제품에 따라 규정 요건이 매우 달라질 수 있으므로, 구체적인 제품 정보가 없으면 맞는 답변을 드리기 어렵습니다. 

 진흥원 해외제약전문가 컨설팅 프로그램을 신청해주신다면 맞춤형 답변을 안내드리도록 하겠습니다. 

*추가 문의사항이 있을 경우 사무국으로 문의 바랍니다. (gbc@kobia.kr)

 연사: Feng Tao

  Q1 

 How long take to get final approval of OTC products? Can you tell the average regulatory process time?

 현재 기준으로 자료 보완을 통해 진행중인 사례는 있으나, 성공한 사례는 아직 없는 것으로 알고 있습니다.

 Q2

 앞선 슬라이드에서 한국 출시/발매일 기준에 따라 중국 등록에 어려움을 설명해주셨었는데, 15~17년 사이에 부분적 보완했던 사례를 공유 받을 수 있을지요?

 해당 슬라이드의 내용은 한국 기업과 컨설팅 하는 과정에서 얻은 컨설턴트 개인적인 결론입니다. 또한 해당 부분은 한국 기업 내부적인 정보로, 공개하기 적절치 않음을 양해 부탁드립니다.

 Q3

 In accordance with SFDA complicated RA is not solicited yet then is there any fast track for permeation into emerging Pharma market in China?

 중국의 수입의약품 등록 규정은 지속적으로 업데이트/보완되고 있습니다. 의약품 종류마다 규정 요건도 매우 큰 차이를 보입니다.

 만일 컨설팅을 신청해 주신다면 귀사에서 보유한 의약품의 구체적인 정보를 토대로 적합한 자료를 제공해드리겠습니다.

*추가 문의사항이 있을 경우 사무국으로 문의 바랍니다. (gbc@kobia.kr)