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| NAVIGATING THE CHINESE REGULATORY LANDSCAPE: KEY CONSIDERATIONS FOR ACHIEVING FAST TRACK APPROVALS IN A RAPIDLY DEVELOPING MARKET |
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| OVERVIEW |
| PAREXEL experts will provide current guidance on a range of topics critical to achieving long-term success when considering how to access the emerging market potential in China for pharmaceuticals, biologics and medical devices. |
| Areas of discussion will include:
- Current priority review expectations in China and how these can be leveraged to expedite review and approval
- The new "fast track" approval pathway that the Chinese Center for Drug Evaluation (CDE) implemented recently, that uses existing clinical data for drugs that have been approved outside of China
- As part of the "fast track" pathway, the advantages of orphan drugs and breakthrough therapies (including medicines for treating serious life threatening diseases), as well as those drugs that can meet unmet medical needs or have shown significant improvement over existing options
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| Our former NMPA and US FDA experts can also provide insights on the following topics:
- Critical considerations for biosimilar product development in the United States and China
- Effectively managing the current expectations for developing a complex generic drug
- Current medical reimbursement policies in China
- Key considerations when developing an orphan drug or an oncology product
- How developments in China’s digital health policy and practice may impact organizational decisions
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| Our PAREXEL clinical and regulatory experts can help to navigate the current CDE processes and guide you every step of the way to bring your products into the China market in an efficient and cost-effective way.
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Featured PAREXEL speakers
- Vincent Duan, Principal Consultant, PAREXEL Consulting
- Frank Gao, Principal Consultant, PAREXEL Consulting
- Al Bellibas, Vice President, Early Phase Scientific Medical Affairs, PAREXEL
- Shaun Martin, Vice President, Early Phase Scientific Affairs, PAREXEL
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To register, please complete the information below. You also have the option to meet with one of our subject-matter experts after the presentation.
Meeting times differ by location. See details in grid below.
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| Date |
Time |
Location |
| October 30th |
9-10:30 a.m. with a light breakfast served |
Iselin, NJ: Renaissance Woodbridge Hotel, 515 US Highway 1 S, Iselin, NJ 08830-2010
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| October 31st |
8:30 a.m. – Arrival and breakfast
9:00 a.m. – Symposium start
10:30 a.m. – Q&A
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Raleigh/Durham, NC: PAREXEL, 2520 Meridian Parkway, Durham, NC 27713 |
| November 1st |
9-10:30 a.m. with a light breakfast served |
Chicago, IL: Hilton Chicago/Magnificent Mile Suites, 198 E Delaware Place, Chicago, IL 60611 |
| November 5th |
10-11:30 a.m. followed by a light lunch and tour of facilities |
Los Angeles, CA: PAREXEL, 1500 E. Chevy Chase Dr. Suite 200, Glendale, CA 91206 |
| November 6th |
10-11:30 a.m. followed by a light lunch |
San Diego, CA: Hilton La Jolla Torrey Pines, 10950 North Torrey Pines Road, La Jolla, CA 92037 |
| November 7th |
10-11:30 a.m. followed by a light lunch |
San Francisco, CA: Hilton Garden Inn, 670 Gateway Blvd, South San Francisco, CA 94080 |
| November 9th |
10-11:30 a.m. followed by a light lunch |
Seattle, WA: Hilton Garden Inn-Seattle Downtown, 1821 Boren Avenue, Seattle, WA 98101 |
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