This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

7 - 9 September 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

Global Pharmaceutical Regulatory Affairs Summit has been rescheduled!

Due to the increasing travel restrictions from developments with COVID-19 and feedback from key stakeholders, Global Pharmaceutical Regulatory Affairs Summit will be postponed and will now take place on the 7-9 September at the Hotel Palace in Berlin, Germany.

We’re genuinely disappointed to do this but the safety and experience of everyone involved is our top priority and we’re committed to following the guidance of the local authorities.

We thank you all in advance for your understanding and look forward to seeing you in September.

Registered Attendees: Your registration will automatically carry over to the new dates and you do not need to re-register. Should you have any questions, please contact our customer service team at registrations@informa-ls.com 

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. 

FIND OUT MORE
Regulatory Information Management

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

FIND OUT MORE
Regulatory Affairs in Global Markets

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

FIND OUT MORE
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.

FIND OUT MORE

The News!

All articles below have been provided by Pink Sheet

EU Panel Outlines Practical Way Forward With Big Data
DOWNLOAD FREE ARTICLE
Woodcock: The US FDA Sets The Stage For Global Quality Dossiers
DOWNLOAD FREE ARTICLE
Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges
DOWNLOAD FREE ARTICLE

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

Get the latest event updates

Sign up to get the latest event updates and information.

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.

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.

Informa Connect's 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.

DELIVER A PRESENTATION AT GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS DIGITAL WEEK

Sponsor this webcast series, 24-25 June 2020 to engage prospects, reinforce your thought leadership status, and raise your profile — all while generating leads.

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@informaconnectls.com | +44 (0)20 3377 3237