Home  |  About Us  |  Services Jobs Drug Development Boot Camp BiosimilarsLatest Regulatory Updates  |  Diabetes Webinars  | 
Speid & Associates Webinars
  |  Contact Us
Free Audio Launch File  |  Keep Up To Date
 
 
Please use this form to purchase access to both upcoming webinars and past webinars.

Upcoming Webinars


Past Webinars






Upcoming Webinars

(Click here for past webinars)

Please make all your selections and
click Check Out.
Upcoming Webinar Pricing
$ 0.00 for non-clients, complete series of 5 Webinars for $ 250.00
$ 0.00 for clients, complete series for 200.00
 


The Diabetes Series 2008
Title Code Speaker Date Descrption  
Complete Series $ 250.00
Each webinar $ 0.00
2015 DRUG DEVELOPMENT BOOT CAMP Expert Drug Development Boot Camp Faculty 11/17/2015 12:00 am A two day intensive training course in drug development. See appropriate website page at www.drugstomarket.com/harvarddrugbootcamp/
RDPF! Special Guest Dr. Tim McDaniel 02/27/2015 12:00 am This Webinar will describe the latest technological advances that can help patients with rare diseases get answers for the etiology of their symptoms. This is a free Webinar. Please register by emailing Dr. Lorna Speid at lspeid@sndtm.com with RDPF! in the subject line. She will then send you the sign up information for the Webinar.
Webinar 1. European Clinical Trials Versus US IND 001 Lorna Speid, Ph.D., RAC 05/04/2009 12:00 am The European Clinical Trials Directive and its implementation has produced an opportunity for harmonization of clinical trials regulations throughout the Member States of the European Union. In practice, the process of harmonization has not been experienced as a smooth one by many companies. During this seminar, a framework will be provided to help participants to better understand the similarities between the IND and the Clinical Trial Application, and how to prepare documentation for these two formats simultaneously. This will be an interactive session, allowing participants to raise real life questions and issues.
Webinar 2. The Changing Regulatory Environment 002 Lorna Speid, Ph.D., RAC 05/05/2009 12:00 am The pharmaceutical industry is one of the most regulated industries that exists. Every aspect of the research, development, sales and promotion of medicines is regulated. To make matters more complicated, these regulations can vary from one region to another, although the International Conference of Harmonization has helped to bring about more harmonization than existed 10 years ago. Companies must navigate the previously developed regulations, and keep abreast of new regulations such as the need for risk management programs, pediatric regulations, the European Clinical Trials Directive, Orphan Drugs initiatives, and the list goes on. This seminar will give the highlights on some of these initiatives and invite discussion and questions from the participants.
Webinar 3. Preparing for a Successful Electronic CTD Filing - Part 1 003 Lorna Speid, Ph.D., RAC 05/06/2009 12:00 am Many companies realize that they need to make preparations for electronic filings, and CTD filings in particular, but they do not know where to start. We will examine some of the issues involved in setting up an electronic document management system. We will examine an approach to compiling a successful electronic Common Technical Dossier filing. This course will be interactive. We welcome those who have experience using templates, setting up electronic systems, and those who are considering this as the next step to the company's development. If there is enough interest future sessions will drill down into more detail on the topics covered during this seminar.
Webinar 4. Pediatric Clinical Trials - US and Europe 004 Lorna Speid, Ph.D., RAC 05/07/2009 12:00 am Most companies have conducted pediatric studies as an afterthought, if at all. This situation is about to change, as the Europeans mandate the conduct of these studies unless a formal waiver is applied and approved. Companies must consider the implications of this regulation for nonclinical toxicology studies and clinical trial designs as early as possible.
Webinar 6. Preparing for a Successful Electronic CTD Filing - Part 2 - Some Aspects of Compiling an Electronic Common Technical Dossier 006 Lorna Speid, Ph.D., RAC 05/18/2009 12:00 am Many companies realize that they need to make preparations for electronic filings, and CTD filings in particular, but they do not know where to start. We will examine some of the issues involved in setting up an electronic document management system. We will examine an approach to compiling a successful electronic Common Technical Dossier filing. This course will be interactive. We welcome those who have experience using templates, setting up electronic systems, and those who are considering this as the next step to the company's development. If there is enough interest future sessions will drill down into more detail on the topics covered during this seminar.
The Seven Things You Need to Know about the Drug Development Process For Rare Diseases RDPF 0 Dr. Lorna Speid 12/03/2014 12:00 am If you are a patient with a rare disease, or the parent of a child with a rare disease, you are likely to be bewildered by the process by which new treatments are developed for rare diseases. This is an opportunity to access unbiased information and ask the questions you have always wanted to ask someone involved in the process. This is a free WEBINAR. Please email Dr. Speid at lspeid@sndtm.com to receive the login information for this important online seminar.
Upcoming Regulatory Webinars
Title Code Speaker Date Descrption  
The Ten Mistakes That Senior Management Teams Make With INDs 24678 Lorna Speid, Ph.D., Richard Kenley, Ph.D. 05/20/2010 12:00 am The achievement of a cleared Investigational New Drug application (IND) is a critical milestone for most small to mid-sized companies. Senior Management teams face many challenges when working on these applications. These are not easy applications to create, and there are many potential pitfalls. During this presentation the pitfalls that CEOs and senior management teams need to be aware of will be identified. A panel session will follow the presentations at which time the audience will be able to address questions to members of the panel.
Past Webinars


(Click here for past webinars)

Please make all your selections and
click Check Out.

After paying for your Past Webinars, you will be sent an email with a link to a page where you may download the slides and the audio file for each Past Webinar.

Past Webinar Pricing
$ 50.00 for non-clients, complete series of 5 Webinars for $ 50.00
$ 50.00 for clients, complete series for 50.00.




 
Past Regulatory Webinars
Title Code Speaker Descrption  
Complete Series $50.00
Each webinar $ 50.00 for audio, slides are included free of charge
Webinar 1. European Clinical Trials Versus US IND 1007 Lorna Speid, Ph.D., RAC The European Clinical Trials Directive and its implementation has produced an opportunity for harmonization of clinical trials regulations throughout the Member States of the European Union. In practice, the process of harmonization has not been experienced as a smooth one by many companies. During this seminar, a framework will be provided to help participants to better understand the similarities between the IND and the Clinical Trial Application, and how to prepare documentation for these two formats simultaneously. This will be an interactive session, allowing participants to raise real life questions and issues.
Webinar 2. The Changing Regulatory Environment 1008 Lorna Speid, Ph.D., RAC The pharmaceutical industry is one of the most regulated industries that exists. Every aspect of the research, development, sales and promotion of medicines is regulated. To make matters more complicated, these regulations can vary from one region to another, although the International Conference of Harmonization has helped to bring about more harmonization than existed 10 years ago. Companies must navigate the previously developed regulations, and keep abreast of new regulations such as the need for risk management programs, pediatric regulations, the European Clinical Trials Directive, Orphan Drugs initiatives, and the list goes on. This seminar will give the highlights on some of these initiatives and invite discussion and questions from the participants.
Webinar 3. Preparing for a Successful Electronic CTD Filing - Part 1 1009 Lorna Speid, Ph.D., RAC Many companies realize that they need to make preparations for electronic filings, and CTD filings in particular, but they do not know where to start. We will examine some of the issues involved in setting up an electronic document management system. We will examine an approach to compiling a successful electronic Common Technical Dossier filing. This course will be interactive. We welcome those who have experience using templates, setting up electronic systems, and those who are considering this as the next step to the company's development. If there is enough interest future sessions will drill down into more detail on the topics covered during this seminar.
Webinar 4. Preparing for a Successful eCTD Filing Part 2. Liquent/Thomson 1012 Tom Delisi Senior Consultant A detailed review of the technical considerations in compiling an eCTD will be presented. This is a very clear presentation of the issues.
 
Past Diabetes Webinars
Title Code Speaker Descrption  
Complete Series $50.00
Each webinar $ 50.00 for audio, slides are included free of charge
Webinar 1 - Diabetes Overview 1001 Dr. Alexander Fleming Dr. Alexander will provide an overview of diabetes (Type I and Type II) and related illnesses, and complications. Obesity, cardiovascular and vascular complications will be discussed. Possible targets and implications of studying these will be considered.
Webinar 2. Nonclinical models for Diabetic Indications. 1002 Dr. Bill Hodnick - Ricerca Biosciences and others Considerations for study designs for different diabetic indications will be presented. Considerations for development of bioanalytical methods and validation of these will be presented.
Webinar 3. Toxicological Evaluation 1003 Dr. Scott Boley, MPI Research An overview of the GLP toxicological studies that must be conducted for Investigational new Drug Applications and New Drug Applications / Marketing Authorization Applications will be presented. Combination products and diagnostic / device products will also be considered.
Webinar 4. Clinical Research for Diabetic Therapeutics 1004 Professor John Baxter, UCSF The metabolic syndrome is a constellation of diseases that includes obesity, insulin resistance and Type II diabetes, high blood pressure and alterations in cholesterol and fat metabolism. This syndrome (also known as Syndrome X) represents one of the largest health threats to the western world today. Treatments for individual components of the syndrome will be very useful in their own right, but also have the potential to influence other facets of this inter-related disease. For example, treatments that reduce obesity should also reduce the risk of developing Type II diabetes.

Professor Baxter will use the development of thyroid hormone analogues to illustrate issues and approaches with the development of novel therapeutics for the treatment of the metabolic syndrome.
Webinar 5. Clinical Development of Diabetic Therapeutics 1005 Dr. Alexander Fleming Ex-FDA, Kinexum LLC Clinical development considerations for diabetes and the complications of diabetes will be presented. This webinar will include protocol designs for novel therapeutic approaches including transplantation approaches.
Webinar 6. Registration Strategies for Diabetic Therapeutics, and Complications of Diabetes 1006 Dr. Alexander Fleming Ex-FDA, Kinexum LLC Registration strategies, registration endpoints, considerations for building registration dossiers will be covered for various types of diabetic therapeutics. There will be opportunities for asking specific questions for currently encountered issues in an anonymous format.



Order Summary
Have you ever contracted with Speid & Associates to conduct regulatory affairs consulting? If so check this box to receive discounts on your Upcoming Webinar order.
Seminar Title Date Code Cost
  Grand Total:   $ 0.00




Check Out


Please complete the following information then click Submit to PayPal to complete your purchase.

Name:
Address:
City:
State:
Zipc Code:
Telephone number:
Email address:
Company Name:
Job Title:
Comments or Instructions
 
All rights reserved by Speid & Associates, Inc.