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Workshop
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Discussion
Topics

How to Best Prepare for a Regulatory Audit: Regulator Perspective

This workshop will cover the aspects of an audit that are the current focus of the MHRA and FDA.  It will provide real-world examples of audit findings and their impacts on pharmaceutical organizations as well as what can be done to mitigate them.  It will also discuss how the MHRA and FDA are beginning to harmonize audit techniques for investigational drug products.

The Case for Investigational Product Pooling

This workshop will contain a discussion of the different options available for pooling investigational products for global studies.  Real-life cases where pooling was done successfully and unsuccessfully will be used as examples to learn when pooling is a viable option for supplying trials.  The discussion will also include how modeling and simulation can be used to support investigational product pooling.

Successfully Removing Expiry Dates from Investigational Product Labels

Eliminating expiry dating from IP labels is being done in a number of countries although this is still an emerging and controversial topic.  This workshop will provide examples of how dates have been removed from labels in many countries and what can be done to educate and influence regulators to accept removal of expiry dates from investigational product labels.  It will identify key information and documentation that has been critical for enabling this practice and discuss what can be done to make this an acceptable practice.

Importance of IVR  User Acceptance Testing to Trial Success

This workshop will describe the role of user acceptance testing (UAT) and how it is critical to IVR performance, including randomization, investigational product supply management, and correct dosing of study subjects.  It will compare the differences between internal and external UAT, listing key stakeholders to involve, identify typical UAT activities and timelines, and describe key criteria to assess during testing.

Biologics – Large vs Small Molecule Drug Programs

This workshop will compare and contrast investigational drug challenges between large and small molecule drug development programs.   It will discuss aspects unique to large molecule drug development, how investigational drug units need to work differently with pre-clinical  development to enhance efficiency, and differentiate timeline challenges between large and small  molecule drug development programs relative to investigational products and other considerations.

Managing Investigational Product Supplies in the Asia-Pacific Region

This workshop will discuss the  challenges in distributing investigational products to clinical sites throughout the entire Asia-Pacific region.  It will identify common challenges in the import, distribution, and export of investigational product at Asia-Pacific study centers.  Examples of successes and failures will be used to provide attendees with the key elements for distribution and trial conduct for studies conducted in Asia-Pacific countries.

Thinking Styles

This highly interactive workshop will discuss the various thinking styles that exist and how we can use them to improve our understanding of the people around us.  It will discuss the varied techniques that are available for communicating with others using different communication styles and how we can use this knowledge to improve working relationships to get the most from interactions.  It will also provide pointers on what avoid in order to not hamper relationships.

Site Selection: Clinical Research Organizations Perspectives

This workshop will discuss the criteria that are used for selecting clinical sites and how CT supplies can be tailored to meet the needs of those sites.  It will show the key areas of focus when auditing a clinical site and define key site performance aspects regarding investigational product management.

Blinding Techniques for Non-Solid Oral Dosage Forms: Beyond Tablets and Capsules

This workshop will focus on the unique challenges encountered when trying to blind non-solid oral dosage forms and unique drug delivery systems such as vials, syringes, or pens. Real-world examples of different techniques will be shared and challenges of blinding these alternate dosage forms will be discussed with a focus on providing solutions that meet the study needs and enable patient compliance.

Managing Investigational Product Supplies in Japan

This workshop will focus specifically on the challenges of managing Japan-centered clinical trial investigational product supplies from a remote project management perspective.  It will identify the key aspects of managing investigational product supplies that are unique to this country and critical for success.  It will summarize key regulatory requirements, cultural differences, and misconceptions in conducting clinical trials in Japan and how they compare to the way trials are supported in EU and US.

Managing Investigational Product Supplies in Latin America

This workshop will discuss the challenges of managing clinical trial investigational product supplies in Latin American countries.  It will identify the key aspects for success of managing investigational product supplies that are unique to these countries.  It will summarize key regulatory requirements, cultural differences, and common challenges in conducting clinical trials throughout the LA region.

How Label Translation Databases Enable Clinical Trial Efficiency

This workshop will discuss using a language translation database for global investigational product study management.  It will identify the advantages and disadantages of using databases to assist in managing a clinical portfolio and compare a database approach to customized, country-based regulatory label review and translation for investigational products.  It will provide the key aspects of maintaining a translation library with respect to language considerations and regulatory changes.