Investigational New Drug Application (IND): When Required and Content of Submission-Louise Johnson, M.S.-05/18/2010 - 8:30am

Event Information
Event Topic: 
Investigational New Drug Application (IND): When Required and Content of Submission
Event Date: 
05/18/2010 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Speaker Information
Event Speaker: 
Louise Johnson, M.S.
Event Speaker Title: 
Senior Consultant
Event Speaker Company: 
Biologics Consulting Group
Event Speaker Bio: 

Louise C. Johnson has over 28 years experience in the biotechnology and pharmaceutical industry. Prior to joining Biologics Consulting Group, Louise spent the past 17 years in regulatory leadership roles at Renovis, Elan Pharmaceuticals, Athena Neurosciences, and DuPont Pharmaceuticals. She has worked with small molecule, monoclonal antibody, and vaccine submissions and has experience with FDA, Health Canada's HPFB, and the UK's MHRA. Her previous work includes the initial IND filing for Tysabri for Athena Neurosciences, approval of 2 anticonvulsants in the US and Canada for Elan Pharmaceuticals, and the initial IND filing a therapeutic vaccine for Alzheimer's disease for Elan Pharmaceuticals.

Event Details
Event Details: 

Combination products and personalized medicine often require firms to be knowledgeable about the different regulatory requirements for devices, drugs, and biologics. Historically, these different product types have been developed and marketed completely independently, resulting in very little cross-over among industries. Learn when an Investigational New Drug application is required for your product, what is required for an IND , and how to write, compile, and submit an IND. This presentation will also discuss FDA’s approach to reviewing INDs and their general expectations of sponsors.

Payment Options Dec 12th Evening Event

Attention B2DG members: You must login to your account first to see the members' early-bird admission rate.
If you are not a B2DG member or if you had missed the early-bird deadline, the registration fee is $20. Please follow these instructions to register.

We use PAYPAL to process your online payment. Print and bring a copy of your online receipt with you. If space permits, walk-ins are welcomed; please be prepared to pay $25 at the door (cash or check). There is no refund, exchange, or transfer. Thank you for your cooperation.
To register now, please select your meal preference from the pull-down menu below and enter the attendee's information. Then click on the "Pay Now" button to reach the PayPal payment page. Each attendee must be registered separately.
Make sure you enter the attendee's meal choice, name, and email address.

Meal Choice
Name of Attendee
Email Address