Best Practices for Global Regulatory Intelligence: Dos and Don'ts

1

• Best Practices for Global Regulatory
  Intelligence Dos and Don'ts

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2

• Instructor Profile
• Dr. David Lim is President and
  Principal of Regulatory Doctor. Regulatory Doctor
  provides Practical, Actionable, and Sustainable
  Solutions in an Integrated, Thorough ("PASS-IT")
  manner. Dr. Lim obtained his Ph.D.
  in biological sciences at the University of
  Missouri-Columbia and published his thesis
  research in the prestigious journal "Science."
  Since then, Dr. Lim has held various positions at
  Duke, Caltech, US National Laboratories, Intrexon
  Corporation, Terumo, US FDA/CDRH, and EraGen
  Biosciences, Inc., A Luminex Company. In 2009,
  Dr. Lim served as a panel member during the FDAs
  Transparency Public Meeting. Prior to founding
  his own consulting firm (www.RegulatoryDoctor.com)
  , Dr. Lim was Senior Vice President of Scientific
  and Regulatory Affairs at Aquavit
  Pharmaceuticals, Inc. in New York.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3

• Description
• This webinar is intended to help you
  get familiarized with the best practices for
  global regulatory intelligence including dos and
  don'ts. This webinar is further intended to
  increase our awareness for the importance of
  implementing a holistic global regulatory
  intelligence program suitable for your medical
  product types.
• It is believed that actionable and
  practical regulatory intelligence can help an
  organization save a significant amount of
  resources (time, efforts and financial). This
  webinar will address the best practices for you
  to take action, significantly benefiting your
  organization in many ways. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4

• Objectives of the Presentation
• The key objectives of the presentation are to
  give better insight on
• Applicable Laws and Regulations
• Regulatory Intelligence for Drugs, Biologics,
  Biosimilars, and Medical Devices including In
  Vitro Diagnostic Medical Devices (IVDs)
• RD, Patenting (IP) and Applicable Regulatory
  Pathways
• Intellectual Property (IP) Issues
• Alignment between Regulatory Plan/Strategy,
  Reimbursement, and IP
• New Requirements to Integrate Risk Management
  Plan (RMP)/Pharmacovigilance (PV)
• FDA Unique Device Identification/Identifier (UDI)
• Detailed Contents
• Common Mistakes Leading to Serious Consequences
  (Patient Safety and Business Operations)
• Practical, Actionable, and Sustainable Solutions
  (PASS)

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5

• Why Should you Attend
• Attend this webinar to adequately develop and
  implement a holistic global regulatory
  intelligence program. 
• Who can Benefit
• Regulatory Affairs
• Management CEOs, VPs
• RD and Product Development
• Legal Counsel and Compliance Officers
• Marketing
• Clinical Affairs
• Consultants
• Contractors/Subcontractors
• Other Interested Parties

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6

• Live Session - How it works?
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf format will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.
• Recorded Session - How it works?
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
7

• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com