FDAnews Announces — Japan’s Pharmaceutical Regulatory Environment: What Will the New Sakigake Pathway Mean for Drugmakers? Webinar, Sept. 30, 2015

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Japan is encouraging pharmaceutical companies to get new products approved first there, or at the very least, parallel to the US and EU, with it’s new “Sakigake” expedited pathway. In this webinar, Alberto Grignolo will share the in-depth knowledge gained during his establishment of PAREXEL’s Japan Consulting Services.

Japan’s Pharmaceutical Regulatory Environment:
What Will the New Sakigake Pathway Mean for Drugmakers?

**FDAnews Webinar**
Sept. 30, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/japanspharmaregenvironment

Japan is encouraging pharmaceutical companies to get new products approved first there, or at the very least, parallel to the US and EU, with it’s new “Sakigake” expedited pathway. Started in April, the pathway is similar to the FDA’s breakthrough designation — potentially cutting approval time in half.

The rewards for doing business in Japan can be high, but so can the stakes. The country’s regulators, long notorious for their opacity, have made efforts to foster much greater openness.

But they still don’t hesitate to wield their authority. Earlier this year, they forced a major international drugmaker to shut down its Japanese operations — production and sales — for 15 days as a penalty for failing to report side effects properly.

In this webinar, Alberto Grignolo will share the in-depth knowledge gained during his establishment of PAREXEL’s Japan Consulting Services. Attendees will learn how the steps, priorities and expectations will differ when meeting with Japanese regulators.

If manufacturers are going to bring drugs to this massive market, they need this information to prepare for its unique challenges.

Register now for Japan’s Pharmaceutical Regulatory Environment: What Will the New Sakigake Pathway Mean for Drugmakers? on Wednesday, Sept. 30, 2015.

Meet the Presenter:
Alberto Grignolo
Corporate Vice President, PAREXEL
A 23-year veteran of PAREXEL, he has most recently established the firm’s Japan Consulting Services during a two-year assignment in Tokyo (2011-2013). He advises clients in the areas of global drug development strategy, and is currently engaged in initiatives that address significant opportunities and challenges in product development and commercialization. A native European, he has also lived in Latin America and Japan, and has been a frequent speaker, program chair, session chair or instructor at more than 120 international conferences, seminars, workshops and courses on drug development and regulatory affairs.

Who Will Benefit:

  •     Executive management
  •     General/corporate counsel
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Sales/marketing personnel
  •     Strategic planning and business development staff
  •     Training personnel

Conference Details:
Japan’s Pharmaceutical Regulatory Environment:
What Will the New Sakigake Pathway Mean for Drugmakers?
**FDAnews Webinar**
Sept. 30, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/japanspharmaregenvironment

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/japanspharmaregenvironment
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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