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18 - 20 October 2016
Maritim proArte Hotel,

Achieve fast and compliant global product approval through direct regulatory authority access and real time updates

Where pharmaceutical regulatory affairs professionals meet

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
Global eSubmissions
  • 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?
Pharmaceutical Labelling
  • 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

Hours of Networking with regulatory authorities, industry leaders, and peers
Top 10 Pharmaceutical Companies Globally
Companies from Across the Pharmaceutical Regulatory Industry


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: 

Meet, benchmark, and be inspired by the industry's leading experts

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:

Focus Days:

Enhanced Networking

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.

A meeting place for pharmaceutical regulatory affairs professionals in Berlin


The splendid avenue "Unter den Linden" with its elegant shops is just a stone's throw away from the hotel. Explore the "genuine" Berlin on foot, with its traditional pubs, fashionable restaurants and cultural highlights. Organic seal of quality for breakfast and lunch. Since January 1st 2007 the hotel is the first in Berlin with an organic certificate.

Friedrichstrasse 151, 10117 Berlin, Germany

Please click here for information on how to reach the hotel and its location.

Reduced Rate Accommodation

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Please click here to book reduced rate accommodation at the Maritim proArte Hotel Berlin where the conference will take place.

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