8 - 10 April 2019
Crowne Plaza Fira Center,
Accelerate global expansion. Minimise time to market. Transform your global regulatory strategy.
Connect with regulators and industry peers from around the world to discuss the latest global requirements and swap registration top tips
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 BRINGING ALL OUR GLOBAL REGULATIONS EVENTS UNDER ONE ROOF
The world of Regulatory Affairs is becoming increasingly integrated. Ideas, people and policies are spread further and faster than ever, the world is listening. And so are we.
This year, we are co-locating our Global Regulatory Affairs Summit and our eRegulatory Summit to help increase this exchange of ideas. Not only will you be able to meet, discuss and network with other regulatory professionals from around the world but you will also get to hear from leaders in the data and submissions worlds to enhance your knowledge of the industry as a whole. We want to guide you to a clear view of the bigger picture.
Industry leaders share their experiences…
Join the Global Regulatory Community
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.