24 - 26 October 2017
Clarion Congress Hotel,
Achieve fast and compliant global product approval through direct regulatory authority access and real time updates
Thank you to everyone who attended this year's Global Pharmaceutical Regulatory Affairs Summit
Where pharmaceutical regulatory affairs professionals meet
Your conference streams are:
Regulatory Affairs in Emerging Markets
- Russian Federal Law 429-FZ: What are the key amendments and impacts on industry?
- Ukraine Ministry of Health’s recently adopted Order No 452: What are the latest updates?
- Understanding latest practical experiences with the Eurasian Union
- Exploring latest regulatory updates in the GCC, Jordan, Iran, Sub-Saharan Africa, South Africa, North Africa and Turkey
- Brazil, Mexico, Chile, Caribbean markets: What are the latest requirements for industry?
- Outlining the regulatory environment in China, India, South Korea, Taiwan and ASEAN countries
- Combined plenary session focusing on health agency interactions in emerging markets and intercultural communication
- EU eCTD Module 1 Specification v3.0: Exploring experiences encountered to date
- Understanding EMA Policy 0070: How will this impact the eCTD format and lifecycle management?
- Sharing experiences with submitting an eCTD in Australia, China and Thailand
- US Module 1 v2.3: What are the latest updates and practical implications for industry?
IDMP Preparation Focus Day
- Reviewing EMA timelines for IDMP Iteration 1 and the impact of a phased approach on industry
- Controlled vocabularies: What is the importance of updating these for IDMP implementation?
- Practically implementing a Master Data Governance approach: How can IDMP challenges be overcome?
- How can communication be improved between pharmacovigilance, labelling, regulatory affairs, and risk management, to ensure compliant and timely labelling updates?
- Serialisation and coding requirements: Examining strategies to overcome the associated labelling challenges
- Risk minimisation: How can effective labelling reduce medication errors?
- How can industry practically meet the authority expectations regarding PRAC implementation timelines?
- Assessing the importance of translation and readability when updating labelling globally
- What are the current EU guidelines surrounding the PIL and SmPC?
- Sharing best practice for ensuring a robust CCDS from a global perspective
Bringing 200+ Pharmaceutical Regulatory Affairs, eSubmissions and Labelling experts together from across the globe
FREE WEBINAR - ON DEMAND
ISO IDMP: Latest updates and timelines
This webinar will provide an outline of the IDMP standards and guidelines as well as assessing the roadmap and current timelines for IDMP in Europe. Where to obtain IDMP data both internally and externally will be discussed as well as who needs to be involved, and what the next steps be for IDMP should be.
Led by: Dieter Schlaps, Owner, IT-Consulting Life Science, Germany
Due to some technical difficulties experienced, please skip to 5 minutes 36 seconds for the beginning of the webinar.
The webinar slides are available to download at: http://get.knect365.com/cq5264-idmp-webinar-dieter-schlaps
Meet, benchmark, and be inspired by the industry's leading experts
Meet with the pharmaceutical regulatory community for improved knowledge, networking and experience exchange
Collaboration and Feedback
Regulatory Affairs in Emerging Markets: Get your burning questions answered in our; Russian GMP requirements interactive troubleshooting session; Q&A session on registration in Ukraine; Brazil and China Q&A sessions; and Collaboration Zone round tables on Russia & CIS, Turkey & MENA, Latin America. and Asia-Pacific
Global eSubmissions: Join our; interactive round tables to share experiences with EU eCTD Module 1 Specification v3.0; Global Collaboration Zone to overcome challenges with global eCTD requirements; and our IDMP experience exchange as part of the IDMP Focus Day
Pharmaceutical Labelling: Join your peers in an interactive discussion forum examining strategies to improve communication between pharmacovigilance, labelling, regulatory affairs and risk management; overcome labelling challenges resulting from increasing serialisation and coding requirements by attending the in-depth serialisation workshop; and understand best practice for creating a CCDS suitable for global implementation with a dedicated CCDS workshop
Additional Learning Opportunities
Pre-Conference Evening Seminars:
- Best Practice for Conducting Multi-Regional Clinical Trials in the Emerging Markets - Click here for details on this session
- Implementing a Robust Strategy for Managing eSubmissions in a Diverse Global Environment - Click here for details on this session
The Event App
- Log in to the event app to browse the delegate list, access speaker presentations, set up one-to-one meetings and send messages to fellow participants. See updated content instantly, navigate around the venue with maps & floor plans, take part in surveys or polls, and swap your contact details.
Evening Drinks Reception
- Grab a drink and join your peers for an evening of socialising.
3 Conferences in 1 Location
- For the first time ever, Pharmaceutical Labelling has come together with our Pharmaceutical Regulatory Affairs in Emerging Markets and Global eSubmissions conference streams, providing enhanced networking opportunities and a platform for cross-functional discussion.
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.