| Description |
ICH’s implementation of the Common Technical Document is changing the drug regulatory paradigm in an effort to harmonize regulatory activities. By July 2003, all submissions to the EU and Japan are required to be in the format of the common technical document. FDA is rapidly looking to accept the eCTD before the CTD becomes mandatory in the US, so be prepared. The CTD and eCTD offers you the lead-time necessary to ensure the delivery of complaint drug registration dossiers and get new products to market more rapidly and efficiently.
The mission of the 3rd Annual Common Technical Document Conference is to prepare pharmaceutical and biotechnology regulatory professionals for the implementation of the CTD in your organization and to receive thorough understanding of the changing global regulatory environment. On July 29, 2002, we present a full day training course entitled, "Implementing the CTD in the U.S." This course provides attendees with an overview and insight of the impact the CTD has on your organization. We first provide a general overview of the CTD and the effect that the CTD has on each regulatory region. We then examine the CTD and break down the different modules and address potential difficulties in understanding the requirements. The course also reviews specific information on the requirements for the efficacy, safety and quality sections of this dossier. This course is specifically designed for regulatory affairs, clinicians, CMC, medical writers, and regulatory reviewers.
July 30, 2002, kicks off the main conference chaired by Jessica Lefur, Regulatory Director, OSI Pharmaceuticals. We look to examine the current status of the CTD and the eCTD in the EU, US, and Japan and provide a U.S. Pharmaceutical manufacturers perspective throughout the main conference. Featuring presentations from a specially selected diversity of speakers from such companies as Amgen, Biogen, Cato Research, Covance, FDA, OSI Pharmaceuticals, Johnson & Johnson, Pfizer, Pharmacia, and Inc. Research.. We look to meet the following conference objectives during the main conference:
Assess the worldwide regulatory trends and initiatives including recent FDA and ICH guidance’s relating to the CTD
Reduce the time to publish and deliver submissions to global regulatory authorities
Identify how the CTD achieves harmony among the regulatory authorities of the US, EU and Japan
Determine the challenges to expect in adopting the CTD in each region
Receive an update on the progress of the eCTD
Receive practical advice in overcoming some of the challenges faced in implementing the CTD for each region
Establish timelines and milestones for tracking progress related to the CTD and the eCTD
Examine the Quality, Safety and Efficacy requirements and how they have changed and continue to change
Evaluate XML and its role in the eCTD implementation
We have incorporated time throughout the schedule for interaction with your colleagues including breaks and roundtable luncheons. Please take advantage of this event to meet with our knowledgeable faculty and compare notes and establish contacts with others that are currently facing the same challenges as you in implementing a fully compliant CTD. In addition to the hands on experience you gain by attending the 3rd Annual CTD conference, you’ll also receive a set of program documentation for future reference.
|
|
