About Us

Committed to speeding innovation for science-driven organizations, from product ideation through commercialization.

Events

Visit us at the RAPS’ 2016 Regulatory Convergence

Event Date: September 17- 20, 2016

Event Location: San Jose Convention Center

Booth #201

The Regulatory Convergence is an annual multi-day gathering of the global regulatory community. It brings together the profession’s best and brightest to learn, grow, lead and share.

RAPS' Regulatory Convergence addresses today’s biggest challenges for regulatory professionals and regulators including:

  • Adapting regulatory frameworks and policy to respond to scientific advancement
  • Providing new, efficient pathways for product approval
  • Harmonization in countries that have traditionally taken vastly different approaches
  • Creating regulatory frameworks to encourage full competition and innovation
  • Building regulatory capacity
  • Talent management
  • Mergers and acquisitions

Join us at the 2016 RAPS Regulatory Convergence conference, September 17 – 20, 2016, where our experts will be showcasing tools and solutions for:

  • Improving the efficiency of regulatory submissions
  • Protecting IP & reduce risk by managing regulatory content in controlled environment
  • Accelerating time to market along the drug development value chain
  • Enabling communication and collaboration to improve your competitive advantage

Demo Corner

Stop by booth #201 on Monday or Tuesday for a 15 minute demo on the following topics:

10:30am - Document and Submission Life Cycle Management
With the eCTD mandate just around the corner you need to be thinking about

  • Managing submission content in a controlled system
  • Understanding the best way to leverage investment in an eDMS
  • Differences between version control and ICH Lifecycle states

12:30pm- UID & IDMP, Solutions for the Future
They are real and here to stay

  • UDI and integrated content management
  • Using IDMP over the entire Product lifecycle
  • What the standards really say

2:30pm - Tools to meet the e-Mandate Next Year
May 5th is just around the corner

  • Document management, submission management and clinical trial management
  • Where does all the submission content get created?
  • The single source of truth and how to get stakeholders to use it

Expert Corner

Come see us with your toughest regulatory compliance and electronic content management challenges - our experts will be available to discuss and offer advice!

Kyle Boelter
Senior Field Application Engineer at BIOVIA

Kyle has 16 years of experience in the Regulatory profession and consultancy – Regulatory Processes, Document Management, Document Standards and eCTD Submissions for numerous Pharmaceutical and Biotech Organizations. At BIOVIA Kyle has been responsible for supporting multiple solution platforms, LMS, Deviation, CAPA, Cahnge Control, Customer Complaints, Audit Business Objects and eTMF consulting. Previously Kyle worked for publishing and regulatory solution providers Liquent (PAREXEL) - 5 years, Octagon Research (Accenture) - 5 years. Kyle has worked on Clinical Trial Performance Mgt solutions at DecisonView (IMS Health) and Sunshine Act solutions at Pega Systems.



Warren Perry
Compliance Consultant at BIOVIA

Warren Perry has been with BIOVIA for over 15 years and has worked in the Life Sciences industry for over 20 years. During that time he has gained a wealth of experience in areas that include Regulatory Compliance and Publishing and Document Management. Warren has worked for both CDC Solutions and EXTEDO and has been involved in the global configuration and implementation of systems in several major Life Sciences companies



Stop by booth #201 and test your Wii athletic abilities for your chance to win an Apple Watch!


For more information see the RAPS’ 2016 Regulatory Convergence website.

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