Share
Apr
8
Mon
PMA Drafting Seminars
Apr 8 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Jun
10
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Jun 10 @ 11:00 AM – 12:00 PM

LIVE Seminar Online

Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU

  • Date: June 10, 2019 or email us to schedule a date and time
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes

510(k) Success Path

About the Seminar

This seminar is intended to present an overview of the regulatory process for marketing authorization applications (MAAs) for medicinal products for human use to the European Medicines Agency (EMA).

The speaker will present European Union (EU)’s legislation and regulations governing medicinal products.  In particular, the regulatory requirements to obtain an MAA for medicinal products for human use will be presented in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the process and requirements to obtain an MAA in the European Union.

About the Areas to Be Discussed

  1. Applicable laws and regulations
  2. Definitions
  3. Marketing authorization application (MAA) process: centralized, mutual recognition agreements and decentralized.
  4. Pre-submission regulatory guidance for various product types
  5. Pre-submission procedural guidance
  6. Good manufacturing practices
  7. Quality by design
  8. Application templates
  9. Good practices for MAA preparation and submission
  10. Speaker’s practical, actionable and sustainable solutions
  11. Much more

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, and Quality
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

David Lim Photo.JPG

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) 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 and 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 serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry.

Registration Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

  • LIVE (one attendee): $199 
  • Recorded$249 
  • LIVE (≤ 5 attendees): $599 
  • LIVE (≥ 6 attendees): $999 
  • LIVE & Recorded$299 
Share
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Jun 10 @ 2:00 PM – 3:00 PM

LIVE Seminar Online

Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU

  • Date: June 10, 2019 or email us to schedule a date and time
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes

510(k) Success Path

About the Seminar

This seminar is intended to present an overview of the regulatory process for marketing authorization applications (MAAs) for medicinal products for human use to the European Medicines Agency (EMA).

The speaker will present European Union (EU)’s legislation and regulations governing medicinal products.  In particular, the regulatory requirements to obtain an MAA for medicinal products for human use will be presented in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the process and requirements to obtain an MAA in the European Union.

About the Areas to Be Discussed

  1. Applicable laws and regulations
  2. Definitions
  3. Marketing authorization application (MAA) process: centralized, mutual recognition agreements and decentralized.
  4. Pre-submission regulatory guidance for various product types
  5. Pre-submission procedural guidance
  6. Good manufacturing practices
  7. Quality by design
  8. Application templates
  9. Good practices for MAA preparation and submission
  10. Speaker’s practical, actionable and sustainable solutions
  11. Much more

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, and Quality
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

David Lim Photo.JPG

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) 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 and 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 serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry.

Registration Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

  • LIVE (one attendee): $199 
  • Recorded$249 
  • LIVE (≤ 5 attendees): $599 
  • LIVE (≥ 6 attendees): $999 
  • LIVE & Recorded$299 
Share
PMA Drafting Seminars
Jun 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Aug
12
Mon
PMA Drafting Seminars
Aug 12 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Sep
9
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Sep 9 @ 2:00 PM – 3:00 PM

LIVE Seminar Online

Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU

  • Date: June 10, 2019 or email us to schedule a date and time
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes

510(k) Success Path

About the Seminar

This seminar is intended to present an overview of the regulatory process for marketing authorization applications (MAAs) for medicinal products for human use to the European Medicines Agency (EMA).

The speaker will present European Union (EU)’s legislation and regulations governing medicinal products.  In particular, the regulatory requirements to obtain an MAA for medicinal products for human use will be presented in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the process and requirements to obtain an MAA in the European Union.

About the Areas to Be Discussed

  1. Applicable laws and regulations
  2. Definitions
  3. Marketing authorization application (MAA) process: centralized, mutual recognition agreements and decentralized.
  4. Pre-submission regulatory guidance for various product types
  5. Pre-submission procedural guidance
  6. Good manufacturing practices
  7. Quality by design
  8. Application templates
  9. Good practices for MAA preparation and submission
  10. Speaker’s practical, actionable and sustainable solutions
  11. Much more

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, and Quality
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

David Lim Photo.JPG

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) 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 and 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 serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry.

Registration Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

  • LIVE (one attendee): $199 
  • Recorded$249 
  • LIVE (≤ 5 attendees): $599 
  • LIVE (≥ 6 attendees): $999 
  • LIVE & Recorded$299 
Share
Oct
14
Mon
PMA Drafting Seminars
Oct 14 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
Share
Dec
9
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Dec 9 @ 2:00 PM – 3:00 PM

LIVE Seminar Online

Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU

  • Date: June 10, 2019 or email us to schedule a date and time
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes

510(k) Success Path

About the Seminar

This seminar is intended to present an overview of the regulatory process for marketing authorization applications (MAAs) for medicinal products for human use to the European Medicines Agency (EMA).

The speaker will present European Union (EU)’s legislation and regulations governing medicinal products.  In particular, the regulatory requirements to obtain an MAA for medicinal products for human use will be presented in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the process and requirements to obtain an MAA in the European Union.

About the Areas to Be Discussed

  1. Applicable laws and regulations
  2. Definitions
  3. Marketing authorization application (MAA) process: centralized, mutual recognition agreements and decentralized.
  4. Pre-submission regulatory guidance for various product types
  5. Pre-submission procedural guidance
  6. Good manufacturing practices
  7. Quality by design
  8. Application templates
  9. Good practices for MAA preparation and submission
  10. Speaker’s practical, actionable and sustainable solutions
  11. Much more

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, and Quality
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

David Lim Photo.JPG

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) 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 and 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 serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry.

Registration Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

  • LIVE (one attendee): $199 
  • Recorded$249 
  • LIVE (≤ 5 attendees): $599 
  • LIVE (≥ 6 attendees): $999 
  • LIVE & Recorded$299 
Share
PMA Drafting Seminars
Dec 9 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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Feb
10
Mon
PMA Drafting Seminars
Feb 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 8, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the Speaker

David Lim Photo.JPGDr. 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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