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2007
Speakers (2008
Introduction of Speakers will be released
in September) |
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Young Ho Lee
Director General
Office for Health and Industry Promotion of the Ministry of
Health and Welfare |
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Strengthening the Competitiveness of the Pharmaceutical
Industry under the Korea-US FTA |
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As the global pharmaceutical industry is becoming more
competitive in a bid to gain an edge and market share, domestic pharmaceutical
companies are working closely with authorities to strengthen the competitiveness
of the Korean pharmaceutical industry in the global market in order
to develop the pharmaceutical industry as one of growth engines for
future generations. |
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In Kyu Kim
Team Director
Chemistry and Cardiovascular Team Drug Evaluation Department
of the Korea Food and Drug Administration |
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Review and Approval of API Raw Materials and
Finished Products |
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In order to manufacture and export or import API raw
materials and finished products, the manufacturer or the importer/exporter
needs the approval of, or a notification license from, the KFDA or
six regional offices. To pass the review and approval procedure, they
are required to submit a lot of documents, such as safety, efficacy
and clinical data, and quality statistics for new and generic drugs. |
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Sook Young Lim
Team Leader
Office for Health and Industry Promotion of the Ministry of
Health and Welfare |
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Shaping the Future of the Pharmaceutical Industry
with Drug Discovery Support from the MOH |
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In an effort to actively respond to the rapidly changing
global pharmaceutical industry, for example with the FTA (Free Trade
Agreement) between US and Korea, the government is promoting the advancement
of the current system, researching and developing new drugs, organising
the infrastructure and gaining more market share in the international
market. Domestic pharmaceutical companies need to improve global competitiveness
by focusing on R&D activities and other areas. |
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Nilva Ilya
Inspecting Director
Russian Drug Store Chain's Association |
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The Current Situation in the Pharmaceutical
Market in the Russian Federation |
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This lecture highlights the current situation in the
pharmaceutical market in the Russian Federation, with an emphasis
on the special features of this market, which is currently heavily
influenced by government-induced procurement programmes, as well as
marketing mechanisms.
Research reveals the current situation in the market, showing the
main macro-economic indices and factors, including the government
programmes, that are influencing the development of the market,
and representing the marketing information pertaining to the dynamics
of the growth of the local market in terms of price and volume,
giving a thorough analysis of the import and export trends and structures,
and the main players in the market. The presentation focuses on
the purchasing structure of the pharmaceutical industry in Russia,
and emphasises the distribution structure and development, which
is useful for newcomers, giving them information about which method
of entering the market is the most successful.
We are confident that this research will give you a complete picture
of the current state of affairs in the large-volume prospective
Russian market, thus giving you a chance to learn more about promoting
your business there. |
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James Chen
President & CEO
Agno Pharma USA |
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US Pharmaceutical Outsourcing: Opportunities,
Challenges & Client Expectations |
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The US is the largest and most profitable pharmaceutical
market, capturing more than 40% of the global US$600-billion market.
The net profit of the 10 pharmaceutical companies that are among the
Fortune 500 companies is higher than the net profit of the other 490
companies combined. On the other hand, ethical US pharmaceutical companies
have been facing increasing political and economical pressure in recent
years, as evidenced by the sub-par return on investment in ethical
pharmaceutical stocks. The discovery of new and better medicines has
become more challenging and costly; the average cost of bringing one
new drug to market in the US is US$1.2 billion dollars. At the same
time, the generic US pharmaceutical companies are facing intense competitive
pressure from Indian and Chinese pharmaceutical companies. As a result,
US pharmaceutical companies have steadily increased their outsourcing
activities in recent years in an effort to maintain their profitability.
This presentation will focus on the opportunities, challenges and
client expectations of pharmaceutical outsourcing by US companies. |
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Chong Ho Lee
Executive Director
Korea Biotechnology Commercialization Center (KBCC) of the Korea
Institute of Industrial Technology |
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Introduction of the CMO Industry trends and
the KBCC |
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The market size of the biopharmaceutical industry,
which is a high value-added business, is increasing by 20% annually.
The development of biopharmaceuticals requires enormous investments
of money and time for discovery, process development and the construction
of GMP facilities for clinical sample manufacturing, etc. So, development-focused
bio companies need to concentrate their core competencies on the development
of the strategic use of CMOs (Contract Manufacturing Organisations)
for manufacturing. In turn, I'd like to introduce the trends and prospects
of the CMO industry, primarily the role of the CMO and the benefits
for development companies using CMOs. |
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Teera Chakajnarodom
President
The Pharmaceutical Association of Thailand under Royal Patronage |
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The Current Situation in the Pharmaceutical
Market of the Russian Federation |
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This session will focus on Thailand’s healthcare market,
both in the government and private sectors. How is the healthcare
system funded, and who are the healthcare purchasers and providers,
and the consumers? The lecture will also cover the role of the pharmaceutical
industry in Thailand’s healthcare system, its market size, trends
and the growth potential for multinational R&D-based companies
and local generic drug-makers. It will also provide insight into pharmaceutical
trends and future developments in Thailand, as well as the impact
of Thai regulatory and FDA regulations on pharmaceutical investment
from overseas. |
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Kwi Ho Lee
Head
REACH Business Service Center |
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Introduction to REACH and Guidance for Chemical
Industry |
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It will be described the basic concepts of REACH. Pre-registration
and registration procedure will be reviewed for substances, on their
own, in preparations or in articles. How to deal with REACH is also
given to chemical industry in detail. |
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Young Do Jung
Associate
Eco-Frontier |
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Identification and Naming of Substances under
REACH |
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In REACH, 'OSOR(One Substance One Registration)' is
made a rule. In other words, manufacturers who produce identical substance
are required to make joint registration developing registration dossier
together. For this, manufacturers shall be divided into several groups
under the regulation, ‘pre-registration’. Regarding that
‘pre-registration’ is an essential part of such grouping
process, the most important work in pre-registration process should
be to identify substances clearly. This lecture is dealing with principles
on ‘Identification and Naming of Substance’. |
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Jun Yeon Lee
Team Manager
Korea Testing & Research Institute |
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Safety Data Collection & Sharing |
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The information on chemical properties required for
registration under REACH is linked to the manufacture, hazard or import
levels. The Annexes of the regulation specify the standard data requirements
and give rules on the circumstances in which data may be omitted and
when extra data are triggered. Any studies that are technically impossible
can be omitted. Any studies that are technically impossible clearly
can be omitted. The presentation discussion overview of the chemical
test data collection and data sharing. |
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Hee Kyung Bae
Team Manager
TO21 |
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Guidance of Pre-Registration and Data-sharing
for REACH Registrants |
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The REACH Regulation No1907/2006 of December 2006 set
up a system for the Registration, Evaluation, Authorisation and Restriction
of Chemicals that are substances manufactured or imported in the EU
in quantities of 1 tonne or more per year per manufacturer or importer
and establishes a European Chemicals Agency(ECHA). Phase-in substances
that are pre-registered with ECHA will benefit from extended registration
deadlines and the period for pre-registration is from 1 June 2008
until 1 December 2008. Pre-registrants of the same substance in the
list of pre-registered substances will have to establish whether their
substances are indeed the same for the purpose of SIEF(Substance Information
Exchange Forum) formation. And the aims of the SIEF are to facilitate
data sharing and agree on the classification and labelling of the
substances concerned for the purposes of Registration.
In this presentation, the pre-registration process, the formation
of SIEF, data sharing and cost sharing within SIEF based on RIP 3.4
will be discussed. |
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