Share
May
10
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
May 10 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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. Dr. Lim served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share
Jun
13
Thu
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers
Jun 13 @ 11:00 AM – 12:00 PM

LIVE Online Seminar

Best Practices for Communicating and Interacting with FDA Reviewers

  • Date: June 13, 2019
    • This seminar recurs tri-monthly on second Thursdays.
  • Time: 08:00 AM PST | 11:00 AM EST
  • Duration: 60 Minutes

Questions between People

About the Seminar

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.

About the Areas to Be Discussed

  • FD&C Act and its implementing regulations
  • FDA reviewer’s duties and responsibilities
  • Types and characteristics of FDA reviewers
  • Working with (in)experienced reviewers: issues, challenges and solutions
  • Applying emotional intelligence and negotiation skills
  • Dealing with changing scope of information request
  • Dealing with when the reviewer is not making his/her position clear
  • Understanding and analyzing an FDA reviewer’s position: views and comments
  • Responding to the FDA reviewer’s questions and additional information
  • Handling when interaction and communication are not going anywhere
  • Dealing with when retaliatory actions by the reviewer are perceived
  • Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
  • Practical, actionable, and sustainable strategies/solutions

About the Intended Attendee(s)

  • Regulatory affairs in pharmaceutical and medical device industry
  • Quality
  • Legal counsel
  • Compliance officers
  • Consultants
  • Regulatory agency personnel
  • Anyone interested in the subject

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

 

Share
Jul
12
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
Jul 12 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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. Dr. Lim served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share
Sep
12
Thu
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers
Sep 12 @ 11:00 AM – 12:00 PM

LIVE Online Seminar

Best Practices for Communicating and Interacting with FDA Reviewers

  • Date: June 13, 2019
    • This seminar recurs tri-monthly on second Thursdays.
  • Time: 08:00 AM PST | 11:00 AM EST
  • Duration: 60 Minutes

Questions between People

About the Seminar

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.

About the Areas to Be Discussed

  • FD&C Act and its implementing regulations
  • FDA reviewer’s duties and responsibilities
  • Types and characteristics of FDA reviewers
  • Working with (in)experienced reviewers: issues, challenges and solutions
  • Applying emotional intelligence and negotiation skills
  • Dealing with changing scope of information request
  • Dealing with when the reviewer is not making his/her position clear
  • Understanding and analyzing an FDA reviewer’s position: views and comments
  • Responding to the FDA reviewer’s questions and additional information
  • Handling when interaction and communication are not going anywhere
  • Dealing with when retaliatory actions by the reviewer are perceived
  • Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
  • Practical, actionable, and sustainable strategies/solutions

About the Intended Attendee(s)

  • Regulatory affairs in pharmaceutical and medical device industry
  • Quality
  • Legal counsel
  • Compliance officers
  • Consultants
  • Regulatory agency personnel
  • Anyone interested in the subject

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

 

Share
Sep
13
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
Sep 13 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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. Dr. Lim served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share
Nov
8
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
Nov 8 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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. Dr. Lim served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share
Dec
12
Thu
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers
Dec 12 @ 11:00 AM – 12:00 PM

LIVE Online Seminar

Best Practices for Communicating and Interacting with FDA Reviewers

  • Date: June 13, 2019
    • This seminar recurs tri-monthly on second Thursdays.
  • Time: 08:00 AM PST | 11:00 AM EST
  • Duration: 60 Minutes

Questions between People

About the Seminar

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.

About the Areas to Be Discussed

  • FD&C Act and its implementing regulations
  • FDA reviewer’s duties and responsibilities
  • Types and characteristics of FDA reviewers
  • Working with (in)experienced reviewers: issues, challenges and solutions
  • Applying emotional intelligence and negotiation skills
  • Dealing with changing scope of information request
  • Dealing with when the reviewer is not making his/her position clear
  • Understanding and analyzing an FDA reviewer’s position: views and comments
  • Responding to the FDA reviewer’s questions and additional information
  • Handling when interaction and communication are not going anywhere
  • Dealing with when retaliatory actions by the reviewer are perceived
  • Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
  • Practical, actionable, and sustainable strategies/solutions

About the Intended Attendee(s)

  • Regulatory affairs in pharmaceutical and medical device industry
  • Quality
  • Legal counsel
  • Compliance officers
  • Consultants
  • Regulatory agency personnel
  • Anyone interested in the subject

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

 

Share
Jan
10
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
Jan 10 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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. Dr. Lim served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

Share
Mar
12
Thu
LIVE Seminar Best Practices for Communicating and Interacting with FDA Reviewers
Mar 12 @ 11:00 AM – 12:00 PM

LIVE Online Seminar

Best Practices for Communicating and Interacting with FDA Reviewers

  • Date: June 13, 2019
    • This seminar recurs tri-monthly on second Thursdays.
  • Time: 08:00 AM PST | 11:00 AM EST
  • Duration: 60 Minutes

Questions between People

About the Seminar

This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.

About the Areas to Be Discussed

  • FD&C Act and its implementing regulations
  • FDA reviewer’s duties and responsibilities
  • Types and characteristics of FDA reviewers
  • Working with (in)experienced reviewers: issues, challenges and solutions
  • Applying emotional intelligence and negotiation skills
  • Dealing with changing scope of information request
  • Dealing with when the reviewer is not making his/her position clear
  • Understanding and analyzing an FDA reviewer’s position: views and comments
  • Responding to the FDA reviewer’s questions and additional information
  • Handling when interaction and communication are not going anywhere
  • Dealing with when retaliatory actions by the reviewer are perceived
  • Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
  • Practical, actionable, and sustainable strategies/solutions

About the Intended Attendee(s)

  • Regulatory affairs in pharmaceutical and medical device industry
  • Quality
  • Legal counsel
  • Compliance officers
  • Consultants
  • Regulatory agency personnel
  • Anyone interested in the subject

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

 

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Mar
13
Fri
Developing and Implementing a Global Regulatory Plan and Strategy
Mar 13 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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.  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. Dr. Lim served as a member of the advisory board for inspection insider published by the FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

 

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