Course Title:	Life-cycle Planning for Product Safety Evaluation in Support of Benefit-Risk Activities
Date:	January 13, 2010    12:00 PM to 1:00 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:00 PM This webinar will review the need for high quality safety data and explore the general product life-cycle as well as provide an introduction to the Quantitative Safety Analysis Plan (QSAP).
Course Title:	Safety Overview and Guidance Documents
Date:	January 13, 2010    1:15 PM to 2:15 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 1:15 PM - 2:15 PM This webinar will provide a review of the current paradigm for safety and efficacy and explore a new paradigm for safety in clinical development and an overview of FDA Guidances and EMEA risk management guidelines and generating risk information during clinical trials.
Course Title:	Postmarketing Safety Reporting
Date:	January 20, 2010    12:00 PM to 1:00 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:00 PM This webinar will focus on Post-Marketing safety reporting, including adverse events and reporting timelines, best practices, and avoiding pitfalls. Risk management will also be discussed. The presentation will last approximately 1 hour, with ample time for questions and discussion.
Course Title:	Data Monitoring Committee - The Basics
Date:	April 14, 2010    12:00 PM to 1:00 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:00 PM This webinar will focus on the role of the Data Monitoring Committee and the responsibilities of its members in the clinical trial process. It will also describe common pitfalls in managing a DMC and current controversies faced by DMCs.
Course Title:	Overview of BioPharmaceutical Development: Decision Points
Date:	April 21, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM FREE WEBINAR This webinar will present an overview of the major decision points/phases of the biopharma development and approval processes. Ideal for biopharmaceutical professionals seeking a `snapshot¿ overview of the entire process.
Course Title:	Therapeutic Vaccines: Why Traditional Surrogates of Efficacy Fail
Date:	May 18, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM It is widely believed that the first therapeutic vaccine will be approved by the FDA by May 1, 2010. There is still much controversy about the explanation of clinical trial results showing improved survival without improved time to progression or objective responses. This webinar will focus on findings from recent randomized controlled trials clinical trials of therapeutic vaccines in cancer patients and the implications these findings have for the design and interpretation of clinical trials of immunotherapeutics in general and therapeutic vaccines in particular. The presentation will last approximately 1 hour, with ample time for questions and discussion.
Course Title:	Cancer 101: An Overview of Cancer Etiology, Treatment Methods and Mechanisms of Action
Date:	June 09, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM This webinar will provide an introduction to the cancer disease process and an overview of treatment method categories. Ideal for those new to the oncology field who are seeking a basic overview of cancer pathophysiology.
Course Title:	Part 1:Overview to IND-Enabling Toxicology & Safety Programs
Date:	June 15, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM This webinar series will focus on the typical program of GLP preclinical studies most commonly required to support initiation of Phase I/II trials. NOTE: Each webinar may be taken individually Part 1 will consist of a general overview of the various studies making up a typical program, including their sequence, timing and objectives. Relevant international regulatory guidelines will be highlighted, and potential development strategies will be discussed.
Course Title:	Part 2: The Core Requirements - Rodent and Non-Rodent Toxicology
Date:	June 16, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM This webinar series will focus on the typical program of GLP preclinical studies most commonly required to support initiation of Phase I/II trials. NOTE: Each webinar may be taken individually Part 2 of the series will provide a detailed discussion of the acute, range-finding and definitive repeat dose toxicology studies most commonly undertaken in support of an IND. The session will address rodent and non-rodent species selection, protocol design, dose level selection, biomarkers, clinical pathology, anatomic pathology, cardiology, and ophthalmology, and will discuss data interpretation. A critical element to the discussion will be the NOAEL determined in toxicology studies and how it is used to determine the safe starting dose in human studies.
Course Title:	Part 3: Critical Support Studies - Genetic Toxicology and Safety Pharmacology
Date:	June 22, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM This webinar series will focus on the typical program of GLP preclinical studies most commonly required to support initiation of Phase I/II trials. NOTE: Each webinar may be taken individually Part 3 will describe 2 key specialty areas of toxicology, Genetic Toxicology and Safety Pharmacology, both of which are now routine parts of most IND-enabling programs. The webinar will first describe the panel of in vitro (bacterial and mammalian) and in vivo (mammalian) genetic toxicology studies typically employed to evaluate the potential for mutagenicity. Thereafter the standard panel of in vivo and in vitro Safety Pharmacology studies, each addressing a key organ function, will be discussed. Relevant international regulatory guidelines will be referenced.
Course Title:	Part 4: Insights into Planning and Managing an IND - Enabling Toxicology and Safety Program
Date:	June 23, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM This webinar series will focus on the typical program of GLP preclinical studies most commonly required to support initiation of Phase I/II trials. NOTE: Each webinar may be taken individually Part 4 will undertake to present the various critical steps to planning and undertaking a program of IND-enabling preclinical studies and will identify potential pitfalls which can and do arise during the course of a typical program. Presented from an insider¿s point of view, the session will highlight the most common challenges which can arise, and present strategies to avoid or mitigate their occurance.
Course Title:	New Imaging Approaches in Oncology Drug Development
Date:	June 24, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM NEW DATE! This webinar will provide an introduction to imaging approaches used in oncology research to measure the effectiveness of therapies. Traditional anatomical imaging endpoints and combined functional and anatomical imaging with X-Ray, CT, MRI, PET/CT and other topics will be discussed.
Course Title:	Protocol Development for Multi-Discipline Multi-Site GLP Studies
Date:	July 27, 2010    12:00 PM to 1:30 PM   EST
COURSE COMPLETED
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM Cost: $199.00 Part of the Summer Sale Safety studies are no longer merely toxicology studies, now often comprising multiple sites and disciplines. Now, more than ever, bad protocols result in bad studies. In today¿s world of complex safety studies it is critical to have a protocol that is not only well-designed and scientifically sound, but is also user friendly for the technical staff to follow. Protocols must address published guidance documents issued by various agencies, with enough flexibility built in to avoid needless deviations. Many study issues today are the result of poorly written protocols that lack adequate detail and direction resulting in misunderstandings between various parties. It is critical that protocols be written in a manner that meets all regulatory and Sponsor requirements, while allowing all parties to easily understand their individual requirements.
Course Title:	Multiregional Clinical Trials
Date:	August 11, 2010    12:00 PM to 1:30 PM   EST
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM The webinar will provide an introduction to the scientific, regulatory, logistical, and ethical issues involved in the performance of multinational clinical trials.
Course Title:	Update on Recent Initiatives for Harmonization/Globalization of GLP Bioanalytical Method Validation Guidances
Date:	August 19, 2010    12:00 PM to 1:30 PM   EST
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:30 PM This webinar will summarize the recent international initiative to develop a single Bioanalytical Method Validation Guidance that would be used by all of the regulatory agencies around the globe. In recent meetings, consensus from the FDA, HRMA, EMEA, CVG, AAPS, EBF (European Bioanalysis Forum), Health Canada and world Biotech and Pharmaceutical Industry leaders on the best course of action for the harmonization of bioanalytical method validation (BMV) guidance has been delineated. In fact, representatives from the FDA have been pleading for globalization instead of harmonization so as to expedite this initiative. During these meetings, particularly the recent Montreal CVG meeting in April 2010, the FDA provided updates, and consensus was made pertaining to more than ten hot topics applicable to bioanalytical method validation practices, including LBA, biomarkers, PK repeats and ISR, dried blood spots and Part 11. The importance of these consensuses is amplified given the recent EMEA/CHMP BMV draft guidance provided last year, and the revision of the FDA BMV guidance recently announced to be circulated for review as early as next year. The EMEA draft guidance will also be discussed as it applies, as well so as to provide the attendee a complete scope of this paradigm.
Course Title:	The EU Paediatric Regulation: An Overview of the Aims & Requirements of the Regulation
Date:	October 06, 2010    12:00 PM to 1:00 PM   EST
Course Details and Registration
Course Description: Day 1: 12:00 PM - 1:00 PM This webinar will provide an introduction to the European Paediatric Regulation including an overview of what goes into a paediatric investigation plan and the Regulatory approval process. Ideal for those wanting a basic overview of the Regulation and requirements.
Frequently Asked Questions (FAQ) about Webinars   If you have questions or comments, or need additional information or service please contact us at Webinar Courses or (703) 276-0178. We will be happy to assist you.