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Webinar on Implementing Best Practices for Global Regulatory Intelligence Programs

 
  June 02, 2016  
     
 


Compliance Trainings, Online
2016-06-23


Description :

Global regulatory agencies including the United States Food and Drug Administration (FDA) review, approve/register or clear regulatory applications for drugs, biologics and/or medical devices including in vitro diagnostic devices (IVDs). It is imperative that firms identify and map evolving regulatory requirements so that regulatory submissions can be better prepared for and managed with awareness in advance.

This seminar is intended to discuss the best practices for implementing Global Regulatory Intelligence (GRI) programs including dos and don’ts. This seminar is further intended to discuss how to implement a holistic global regulatory intelligence program suitable for your medical product types.

Establishing a practical, actionable and sustainable regulatory intelligence program can help an organization save a significant amount of resources (time, efforts and financial).

In this seminar, the speaker will discuss what firms should consider and address when implementing a holistic global regulatory intelligence program.

Areas Covered in the Session :

Applicable Laws and Regulations

Definitions

Guidance, Rules, and Standards

What to Consider for Regulatory Intelligence of Medical Products

Questions and Issues to Identify and Address

Totality and Flexible Approaches

Interfacing:  Roles and Benefits

Reimbursement and Intellectual Property (IP) Issues

Alignment between Regulatory Plan/Strategy, Reimbursement, and IP

What to Integrate

Detailed Contents

Common Mistakes Leading to Serious Consequences

Speaker’s PASS-IT Recommendations: Best Practices

Who Will Benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

Research & Development

Consultants

Contractors/Subcontractors

 

Anyone interested in Global Regulatory Intelligence Programs

 
 
Organized by: Compliance Trainings
Invited Speakers:

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, 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 eight 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.

 
Deadline for Abstracts: 2016-06-23
 
Registration:

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1785

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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