Regulatory Affairs and Submissions - Tutorial learning opportunities at DIA2012

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA

Pennsylvania Convention Center

#20: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development 
Sun, June 24, 8:30AM - 12:00PM | IACET
Major changes in Japanese pharmaceutical regulations are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major elements of the regulatory system including the Pharmaceuticals and Medical Devices Agency (PMDA), regulatory processes during development (consultations), and J-CTD review. Several development strategies necessary to meet Japanese requirements for new drug approval will be identified. Postmarket surveillance and pricing reimbursement processes will be reviewed, and finally, the impact of the changing regulatory system on global strategies will be identified throughout development, registration, and postmarket stages.

#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them, and How to Respond If Violations Do Occur 
Sun, June 24, 8:30AM - 12:00PM | IACET
This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2012 and beyond (e.g., application integrity policy and GMP/GCP requirements), (2) FDA administrative enforcement weapons and how the Agency uses them (e.g., inspections, warning letters, publicity, recalls, and investigator disqualification proceedings), and (3) the civil and criminal penalties for violations (e.g., seizure, injunction, criminal prosecution). Included in our focus will be FDA's renewed commitment to enforcement as articulated in an August 2009 speech by Commissioner Margaret Hamburg. We also will address how to handle an FDA enforcement action should you face one, particularly in the wake of an inspection or Warning Letter and the impact of the new initiatives related to responding to 483s and Warning Letters implemented in 2009 following Commissioner's Hamburg's pledge to boost enforcement. These interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.

#34: Fourteen Steps from Research to Development
Sun, June 24, 1:00PM - 4:30PM | CME, IACET
There are 14 steps from research to development (R to D) and initiation of phase 3 clinical studies; the majority of time committed to drug development occurs during this period. A discussion of the 14 critical steps from R to D will include identifying ways to streamline the process and interactions with FDA. With each of the 14 steps used to develop the optimal strategic plan, discussion will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth progression through the preclinical process into early clinical programs will be presented in this half-day tutorial targeted to familiarize pivotal staff in start-up companies with the required terminology and functions, pharmaceutical/biological companies that have yet to file INDs, and those who want to improve their early development approach.

#40: Understanding and Navigating the Regulatory System in China
Sun, June 24, 9:00AM - 5:00PM | IACET
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.

#41: Quality Oversight of CROs - Clinical Vendors
Sun, June 24, 9:00AM - 5:00PM | IACET
FDA and EMA communicate at industry conferences, FDA-CTTI meetings, and regulatory agency public meetings. Sponsors and CRO-vendors who are transferred the responsibilities for trial conduct must have in place a vendor management-oversight program and methods, as well as a quality management system and risk management framework for the execution of clinical trials. Building upon this framework and benchmarking to ISO-9001: 2008, Quality Management Systems, this tutorial describes Quality Oversight of Vendors, with the focus on quality systems, quality attributes, and performance monitoring.
 
#42: Regulatory Affairs for Biologics
Sun, June 24, 9:00AM - 5:00PM | ACPE, IACET
Participants in this tutorial will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and gene therapy, and the different ways that CBER and CDER view product development.