Dr. David Lim

Speaker: Dr. David Lim

Webinar Code: OCH 100 422

Webinar Duration: 60(Minutes)

Fundamentals of Regulatory Affairs in Human Drugs

Webinar Date: Friday 13th of September 2019 10:00 AM PDT | 01:00 PM EDT
Available Options
{ For One participant }

{ Unlimited Access for Six months }

{ Live + Recorded webinar }

{ Live Access for 10 Participants }


Why you should attend:

  •      To understand and become familiar with the Fundamentals of Regulatory Affairs in Drugs


Topic Description:

Are you considering transitioning your interest and career in drug regulatory affairs?  If you are in other healthcare and medical industry (devices and dietary supplements), are you interested in learning more about regulatory affairs in drugs?

This seminar is intended to help industry professionals better understand regulatory affairs applicable for human drugs. 

As regulatory professionals, understanding applicable regulatory requirements is of paramount importance so that we can better help the industry to make informed decisions.

This seminar will discuss various topics including US laws and regulations governing human drugs including important FDA guidance documents.  This seminar will further discuss drug development process, good laboratory practice (GLP), good clinical practice (GCP), investigational new drug application (IND) as well as new drug application (NDA).

This seminar will provide great opportunities to become familiar with the regulatory requirements applicable for human drug development and subsequent regulatory approvals.

At the end of this seminar, you will become well aware of and familiar wih regulatory affairs matters applicable for human drugs. 


Objectives of the Presentation:

  •      To understand and become familiar with regulatory affairs in drugs


Areas Covered:

  •       US Laws and Regulations Governing Drugs
  •       FDA Guidance Documents and FDA-(Non)-Recognized Standards
  •       Drug Development
  •       Good Laboratory Practice (GLP)
  •       Good Clinical Practice (GCP)
  •       Investigational New Drug Application (IND): Content and Format
  •      New Drug Application (NDA): Content and Format


Who will benefit:

  •      R&D Scientists
  •      Clinicians
  •      Healthcare Professionals
  •      Regulatory Affairs
  •      Quality Professionals
  •      Compliance Staff and Officers
  •      Attorneys
  •      Clinical Affairs
  •      Consultants
  •      Contractors/Subcontractors
  •      Anyone Interested in the Topic


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.