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June 19-21, 2018
The Aloft Boston Seaport, Boston

Pre-Conference Workshop A
Tuesday June 19, 2018

08:00 - 11.00
Establishing Practices to Work Effectively With & In Emerging Regions
Workshop Leader: Dean Calhoun, President & CEO, Affygility Solutions

As highly potent compounds become increasingly prevalent, there is a trend towards an increasing investment in facilities and worker training to develop these compounds in emerging areas such as India, the Middle East and North Africa (IMEA) region. It’s clear that working in these areas
poses a number of unique challenges, and this workshop will be devoted to discussing strategies to identify and overcome these setbacks.

Attendees will discuss:

  • Investigating the regulatory landscape governing potent compound development in emerging markets
  • Understanding the cultural aspects of working with organizations in emerging regions – what are the most effective ways to establish a safety culture?
  • Risk assessments on a global scale – how to establish best practices

Dean Calhoun, President & CEO, Affygility Solutions

Pre-Conference Workshop B
Tuesday June 19, 2018

11.30 - 14.30
Navigating the Potent Compound Regulatory Landscape
Workshop Leader: Reinhold Maeck, Head of Corp EHS Regulatory Intelligence, Boehringer Ingelheim

Regulations governing the development, handling and manufacturing of highly potent compounds are becoming increasingly complex, and it’s clear that the expectations of the regulators don’t always align with realistically attainable standards. This workshop will analyze the current regulatory frameworks in place and enable you to optimize your work in this area.

Attendees will discuss:

  • What the regulators are looking for and how you can meet these expectations effectively
  • Understanding how the European regulatory landscape impacts on US regulatory frameworks
  • How regulatory considerations impact containment and cleaning limits
  • Understanding and discussing the quality of documentation and experiences with regulators around
    ADEs and PDEs

Reinhold Maeck, Head of Corp EHS Regulatory Intelligence, Boehringer Ingelheim

Pre-Conference Workshop C
Tuesday June 19, 2018

15.00 - 18.00
Comprehensive Occupational Exposure Banding: Insights For Handling Novel Potent Compounds
Workshop Leader: Bob Sussman, Managing Director, SafeBridge

This workshop will improve industry consistency by defining methods to use limited or early-stage data to assess the hazard potential of development compounds. This session will also provide insights into handling recommendations and basic descriptors of safe work environments based on categorization. Qualitative health-based approaches have been developed to assess and communicate the potential health hazards of compounds to workers. This workshop will also explore new case studies discussing how to handle a variety of NCEs.

Attendees will discuss:

  • Assigning banding classifications and creating an industry standard
  • Ensuring equipment meets requirements and development demands
  • Best-practices for assessing novel potent compounds

Bob Sussman, Managing Director, SafeBridge