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Webinar On The FDA Drug Approval Process

 
  November 28, 2014  
     
 


Compliance Trainings, Canada
2015-01-15


This web seminar provides an overview of the entire FDA Drug Approval Process. This seminar will cover FDA requirements from discovery.

We will begin by developing a molecule, testing it, going through the IND process, clinical testing and finally the NDA process. We will also discuss IND/NDA submission preparation, in-vitro studies, nonclinical studies and human clinical trials. Also discussed will be the underlying scientific and regulatory principles involved in the entire Drug Development Process. This web seminar will also provide a foundation of knowledge for those who require an understanding of the entire FDA Drug Approval Process.

Areas Covered in the Session :

Understand the FDA drug research requirements

Learn about IND process

Learn about Clinical testing requirements

Learn about NDA process

Learn about in-vitro and nonclinical testing

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Drug Discovery Personnel

Legal Personnel

Personnel who require a general understanding of the FDA Drug Approval Process

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

 
 
Organized by: Compliance Trainings
Invited Speakers:

Speaker Profile

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.

 
Deadline for Abstracts: 2015-01-15
 
Registration:

To register this webinar

https://compliancetrainings.com/siteengine/Login.aspx

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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