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Grand InterContinental Seoul Parnas

521 Teheran-ro

Gangna-gu

Seoul, 06164

Korea, Republic of

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Camargo Pharmaceutical Services CEO Ken Phelps is traveling to Seoul to give a seminar on 505(b)(2) Opportunities on Thursday, December 7. The seminar, entitled Position for U.S. Commercial Success: 505(b)(2) Strategy for Regulatory and Market Success, will involve a talk by a pioneer in drug development in the FDA regulatory pathway provided for in Section 505(b)(2). In addition, the seminar will include ample time for questions and answers, lunch and networking, and a roundtable discussion with conclusions relevant to drug developers in Korea. The seminar has space for 100. Register today!

Agenda:

9:30 am: Registration and Networking

10:00 am: Main Seminar:

How to Use 505(b)(2) to Achieve US Commercial Success

This seminar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development, which enables a lower cost, lower risk, and faster path to regulatory approval and market. When properly executed, 505(b)(2) drug development averages 3.5 years and $20 Million to NDA approval in comparison to 11.5 years and $2.6 Billion for 505(b)(1) drug development to NDA approval.

Focusing on high-level strategies, this seminar will clarify common misconceptions associated with 505(b)(2) drug development and emphasize benefits of 505(b)(2), including:

  • Why 505(b)(1) guidance cannot be applied in 505(b)(2) and results in a clinical hold

  • Why the Pre-IND meeting provides the crucial link to a successful 505(b)(2) NDA

  • Reference Listed Drug (RLD) – why it isn’t necessary or required

  • How a 505(b)(2) NDA differs from a 505(b)(1) NDA

  • Which clinical studies are / are not necessary for 505(b)(2)

In addition, in discussion, we will uncover ways to identify products which will succeed with advanced strategy through the US 505(b)(2) regulatory pathway.

11:30 am - 12 pm: Questions and Answers

12 - 1 pm: Lunch and Networking

1 - 2 pm: Roundtable discussion and conclusions


Speaker:

Kenneth V. Phelps

President and CEO, Camargo Pharmaceutical Services

Ken Phelps is co-founder and Chief Executive Officer of Camargo. He has over 40 years of industry experience, including a number of executive-level positions in areas such as quality control, project management and regulatory, clinical and medical affairs.


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Grand InterContinental Seoul Parnas

521 Teheran-ro

Gangna-gu

Seoul, 06164

Korea, Republic of

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