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21 - 23 April 2020
Hotel Palace Berlin,
Berlin, Germany

Where regulatory meets e-regulatory: Bringing answers to the pharmaceutical industry

Take your strategy to the next level with leading advice from Regulatory Authorities, key stakeholders and global perspectives

The home of RIM, eSubmissions, Global Regulatory Markets and Filing Variations

EARLY-BIRD SAVINGS

Secure your place before Friday 13 December 2019 to save up to £1100!

Building capabilities and connections for global regulatory success

Take a look at what's on offer below...

Global eSubmissions

The Global Roadmap, eCTD 4.0, SPOR. 

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Regulatory Information Management

Regulatory Information Management: It's time to harness the true value of your data

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Regulatory Affairs in Global Markets

APAC.CIS.LATAM. You Aim To Work Everywhere. Here's How You Do.

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Workshop: Filing Variations

Get speedy regulatory approval and ensure your filing variation procedures are cost-effective.

Run by Global Pharmaceutical Regulatory Affairs Summit's official training partner, Pharmaceutical Training International.

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Join the global regulatory community

170+
Regulatory professionals from every corner of the industry
100+
Companies working on their regulatory strategies
14
Countries covered by expert speakers

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State of the industry report 2019


Market growth is shifting toward emerging markets in Asia, Latin America and elsewhere, where pharmaceutical sales are forecast to expand at double digit rates. Meanwhile, updates on global eSubmissions, plans for  implementing eCTD within National Procedures, and SPOR are now taking hold. For those in regulatory affairs and information management, there are numerous challenges ahead as they plan their regulatory strategy.

In February 2019, the Knect365 Regulatory Series conducted a survey of regulatory professionals around the world on the state of the industry in 2019. Based on 217 responses, this final report reveals insights into the biggest challenges the industry is facing and the hurdles of the current political environment.

The News!

All articles below have been provided by Pink Sheet

US FDA’s BREXIT: One staffer moving, but impact still may loom large
GET THE FULL ARTICLE HERE
EMA set for more staff losses & activity cuts next year
GET THE FULL ARTICLE HERE
‘Rule Out No-Deal Brexit,’ BIA Tells Government
GET THE FULL ARTICLE HERE

THERE'S SOMETHING ABOUT CHINA!


China is an attractive target for pharmaceutical companies and other clinical research providers. With 58% of the country’s 1.4 billion residents living in urban areas, China promises access to more patients, in greater concentrations, than most other markets, as well as the opportunity to establish trials with treatment-naïve patients. These figures have given rise to legislation seeking to improve access to medicines and the Chinese government has recently taken unprecedented steps to improve its healthcare and regulatory system. However, in a recent survey, we asked which region is most challenging for regulatory approval, and the most common answer – with 24% of respondents – was China.

Knect365 Regulatory Series have put together a paper which explores the changes and challenges to the Chinese regulatory landscape, including the restructure of the Chinese FDA, introduction of fast-track approval and acceptance of Multi-Regional Clinical Trial data.

CONNECT WITH KEY BUYERS AT GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT 2020 IN BERLIN


Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.  

Contact Dylan Smith: DSmith@knect365lifesciences.com | +44 (0)20 3377 3237