21 - 23 April 2020
Hotel Palace Berlin,
THANK YOU TO EVERYONE WHO ATTENDED THE 2019 GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SUMMIT!
Stay tuned for 2020...we are working on an even more exciting agenda to ensure the latest updates from the industry's best!
eRegulatory Digital Week
New in 2019! To compliment the success of the face-to-face event, KNect365 is pleased to introduce eRegulatory digital week. Raise your profile in the market, engage prospects, and reinforce your thought leadership status — all while generating highly qualified leads!
The eRegulatory webinar series will gather innovators looking for regulatory solutions to their 2019 drug esubmission and regulatory information management strategy challenges. Download the eRegulatory Digital week prospectus to learn more about how you can generate fresh leads white demonstrating your presence as a market leader.
Building capabilities and connections for global regulatory success
Discuss the impact of the regulatory reform in Asia Pacific
- Practical considerations for product approval in China
- Explore strategies for successful product registration in India
- Gain updates on the regulatory harmonisation efforts in the ASEAN region
Overcome obstacles to regulatory approval in Russia, CIS & Turkey
- Navigating Russia: Document preparation, serialisation and labelling and GMP Inspections
- Best practices for registrations across the CIS region
- Assessing the regulatory structure and challenges in Turkey
Review the current regulatory landscape in Latin America, Africa and the GCC
- Industry top tips for successful registrations in Brazil, Argentina and Mexico
- Break into Africa! Hear the latest on regulation efforts on the continent
- Your path to compliance in the GCC countries
Optimise your global submissions strategy. Through access to regulators and key industry players, we cover all the critical trends and updates from around the world, including:
- Implementing eCTD within National Procedures
- Outlining the Current Regulatory Submissions Status in Jordan
- Discussing the Latest Updates from Canada: Implications for Industry
Telematics & Regulatory Information Management
RIM.IDMP.SPOR – We've got it covered, have you? Hear from industry on the following:
- Improving data quality by implementing SPOR
- The latest on IDMP timelines
- Feedback on the Falsified Medicines Directive
Join us and take your company from complacent to compliant.
Filing Variations Focus Day
Get to grips with your filing variations approach. Hear the latest updates:
- ICH Q12
- Grouping and work sharing strategies
- Filing variations across the globe
This is your chance to pick up top tips and tricks for building a successful variations strategy.
In 2019 we are expanding your horizons…
The world of regulatory affairs is becoming increasingly integrated. This global regulatory event will help you spread ideas, policies and networks further and faster than ever before.
Book now to:
- Increase the exchange of ideas and enhance your knowledge
- Meet, discuss and network with regulatory professionals from around the world
- Take guidance from leading experts in data and submissions
- Get a clear view of the bigger picture
Join 200+ professionals from over 100 companies in Barcelona at this leading networking and knowledge hub for the regulatory industry!
Industry leaders share their experiences…
Join the Emerging Markets Regulatory Community
State of the industry report
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.
All articles below have been provided by Pink Sheet
US FDA’s BREXIT: One staffer moving, but impact still may loom large
EMA set for more staff losses & activity cuts next year
‘Rule Out No-Deal Brexit,’ BIA Tells Government
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.
Pharmaceutical Training International | PTI
PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We deliver CPD certified training on a wide range of topics including R&D, pre-clinical, clinical, manufacturing, regulatory affairs, pharmacovigilance, biotech, business strategy and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.