25 - 27 April 2017
Hotel Meliá Avenida América,
Connecting RIM, IDMP and eCTD professionals to drive regulatory strategies through authority access and industry expertise
Learn From Senior Specialists in RIM, IDMP and Global eCTD
Conference 1: Regulatory Information Management & IDMP Compliance
- Ensuring high quality data: effective cleaning strategies
- Integrating CMC changes into RIM systems
- Working across departments to create end-to-end RIM processes
- Implementing RIM projects in SME companies
- IDMP implementation updates plus Master Data Management
Conference 2: Global eCTD Management
- Progress in the GCC, South Africa, Thailand, China and CIS countries
- EMA Policy 0070: How will this impact industry?
- eCTD v4.0: Latest developments, practicalities and implications
- Changes related to eAF and CESSP as of April 2017
- Regulatory agency feedback from Oman, Spain, Belgium and Finland
Filing Variations Symposium
- Implementing global variation strategies: What's working?
- Navigating regulatory requirements in Brazil
- Grouping and worksharing initiatives: Industry benchmarking
- Quality documentation: What are regulatory authority expectations?
- Regulation 712/2012: Sharing experiences and challenges
Connecting the Regulatory Community
Influential regulatory speakers and thought leaders
Free On-Demand Webinar with Andrew Marr
Practically preparing for IDMP and examining the latest status and timelines
Hear from Andrew P Marr for direct feedback and take away messages surrounding IDMP implementation:
- Clarifying the current status and timelines for IDMP
- Discussing the latest priorities and updates from the EMA
- Exploring how companies are preparing for IDMP implementation
- Outlining how the updated IDMP timelines can be leveraged to improve business operations
Andrew P Marr, Managing Director, Marr Consultancy Ltd., UK
Please note the slides available for download have been updated slightly since the live webinar recording.
Watch the highlights from our 2016 event
A very big thank you to everyone who attended the 2016 event; it was great seeing so many familiar faces, as well as meeting lots of new ones. Relive the week in our highlights video, or if you couldn’t make it, see what you missed out on and hopefully we’ll see you next year.
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.