DIA Annual Meeting 2013 Preview
Necessity, they say, is the mother of invention. The pharma industry has faced many challenges in recent years and when its need was greatest, it did not hesitate to innovate. Many of these changes are revolutionary and all will be covered at the 49th Drug Information Association (DIA) Annual Meeting. Industry professionals will be converging on this event to hear about the latest in the core topics which are changing the face of the pharma industry.
Pharma is global, and dealing with the intricacies of international pharma legislation can be an extremely tricky business. Several streams will be totally dedicated to the topic of regulation: one will be dedicated to regulation for advertising, while another will cover more diverse topics including engaging with regulators, problems which can be encountered in specific countries and how to ensure compliance with regulation.
Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."
Karen E. Jaffe, MBA,MS,MSc,RAC
Alfred Mann Institute, United States
Several legislations have been introduced calling for regulatory reform for the drug approval process. FDA is under pressure from industry to enable a regulatory framework for translational medicine but at the same time preserve the public health. This session will discuss impacts to the pharmaceutical industry and investment community as well as the patient community.
#50: Understanding and Navigating the Regulatory System in China
Laurence Bin Huang, MBA,MS
Executive Director, Regulatory Affairs
AstraZeneca Pharmaceutical Co., Ltd., China
Wendy Yan, MD,MBA
Global Regulatory Strategist
Bayer Healthcare Co. Ltd, China
This tutorial will provide an overview of the regulatory system in China, including the agencies and institutions at the central government and provincial levels, as well as their roles and responsibilities. Various regulations for product registration, clinical trials, and safety reporting will be presented, and the regulatory pathways and strategic considerations for clinical trial and marketing applications will be discussed. A step-by-step roadmap of how to navigate the regulatory system in China for clinical trial approval and product registration will also be discussed. This discussion will include key points to consider, strategies, and tactics.
Another hot topic is informatics. Big data and the cloud are here and people in the pharma market are keen to learn how to make them work to increase efficiencies and cut waste. All steps of the information chain will be covered from collecting, accessing and validating to analysing, visualising and standardising data. With the introduction of all of these processes and technologies, transitioning is also an important topic as making a leap unassisted may be difficult or even unwise.
That Awkward Stage: Transition from Paper Trial Master File to eTMF
Denise Derenzo Lacey, MA,MS
Halloran Consulting Group, United States
In this session, we will explore best practices for making the transition from a paper to electronic trial master file (TMF), from the different perspectives of an eTMF vendor, a clinical operations sponsor, and an electronic document management system manager.
Data from Everyone: Using Smartphones and the Internet to Connect with Subjects
Anne M. Zielinski, MBA
Global Lead, Patient Cloud
Medidata Solutions Worldwide, United States
The rapid proliferation of mobile communications and the high penetration of the internet in the developed world provide opportunities to collect data from subjects. This session will explore these opportunities and their real-world application.
Many companies seeking to save costs are interested in both outsourcing and offshoring. While this can solve problems and reduce costs, it does not come without issues. Managing relationships with CROs and other companies is paramount to ensuring that both partners can work together to create a mutually beneficial arrangement.
The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Denise A Calaprice-Whitty, PhD,MS
The Avoca Group Inc., United States
Data from 2013 State of Clinical Outsourcing research focused on risk management will be shared. A panel of industry experts will provide their perspective on the data and their predictions of future trends
Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial
Mary Ann Sellers, MSN
Senior Project Leader
Duke Clinical Research Institute, United States
This session will describe successful strategies used by a multi-partner collaboration to manage challenges encountered in an ongoing “megatrial.” The team will share structural and operational models that have been used to drive novel solutions.
About the Keynote
A hot contender for most interesting CV in the world, this year’s keynote speaker Daniel Kraft MD has a background from Brown, Harvard and Stanford. He is Executive Director of FutureMed, Singularity University a program dedicated to exponentially growing technologies which may bring about the future of medicine. He is a scientist who has been published in Nature and Science and a Ted Talks speaker. As if all of this wasn’t enough, he’s also an f-16 pilot and a finalist for astronaut selection.