Events
July 2010 - Cato Research Presents at BIOCOM CRO Workshop
Presentation Details: Pre-IND Meetings and IND Submissions: Lessons Learned
Presented by Sybille Sauter, PhD, RAC
Regulatory Scientist, Cato ResearchThis educational workshop will provide an overview of strategic regulatory considerations and lessons learned from early-stage drug development activities such as pre-IND meetings and IND submissions. Companies sometimes ponder whether or not to request a pre-IND meeting. During the seminar, we will discuss pros and cons related to pre-IND meetings and present some real-world examples. In addition, we will discuss advantages and challenges related to authoring INDs for electronic submissions, as well as the best practices for addressing each challenge in a time- and cost effective manner. To facilitate a smooth review process, authors must plan for current FDA reviewing styles and implement strategies for successful re-use of document content, style, and format for a consistent and clear message across the entire eCTD submission for ease-of-review by the FDA. Best practices and recommendations to address common problems with the generation of INDs will be presented. Last, we will briefly touch on similar regulatory processes for early-stage drug development activities in Europe such as clinical trial applications (CTAs), scientific advice, and protocol assistance. Following the presentation there will be a panel discussion with regulatory compliance and quality experts from the local biotech community
For more information: BIOCOM Event Calendar
August 2, 2010 - 6:00 PM: Cato Research Presents at NC East SoCRA Chapter Meeting
Presentation Details: Informed Consent Content & Process Requirements
Presented by Amber Barnes, PhD, RAC
Regulatory Scientist, Cato ResearchDr. Barnes' presentation will focus on the elements of the informed consent document, and the components of the process. Industry specific scenarios will be presented to reinforce important concepts, for example: evaluating and documenting capacity to consent, voluntariness, HIPAA authorization, withdrawal of consent, and more. Discussions will also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research. CREDIT HOURS: This program offers 1.0 SoCRA CEUs
Venue: Cato Research
4364 S. Alston Avenue
Durham NC 27713
For more information: North Carolina (East) SoCRA Chapter News
October 8-12, 2010: Cato Research Presents at 35th ESMO Congress
Presentation Details: A prospective, randomized, double-blind, placebo controlled, group sequential trial of PAS for the treatment of advanced pancreatic cancer
Presented by Margaretha Oortgiesen, PhD, RAC, CCRP
Vice President, Drug Development
Managing Director of Cato Research, Durham NCVenue: Milano Convention Centre and Fiera Milano Congressi
Viale Lodovico Scarampo - Fieramilanocity
20145 Milan, Italy
www.fieramilanocongressi.it
For more information and to register: 35th ESMO Congress