Share
Dec
10
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Dec 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: December 11, 2017 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
Dec
11
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Dec 11 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: June 13, 2017
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. 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 recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  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
Mar
11
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Mar 11 @ 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: December 11, 2017 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
Mar
12
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Mar 12 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: June 13, 2017
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. 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 recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  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
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: December 11, 2017 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
Jun
11
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Jun 11 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: June 13, 2017
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. 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 recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  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
9
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Sep 9 @ 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: December 11, 2017 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
Sep
10
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Sep 10 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: June 13, 2017
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. 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 recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  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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Dec
9
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Dec 9 @ 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: December 11, 2017 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 
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Dec
10
Tue
CE Mark Content and Format for a Technical File and Design Dossier
Dec 10 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

CE Mark: Content and Format for a Technical File and Design Dossier

  • Date: June 13, 2017
  • NOTE: This seminar recurrs tri-monthly (every 3 month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes
EU 27 Flags
CE Mark

About the Seminar

This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)).  In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.

*: It refers to “Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough” or (“PASS-IT”) manner.

In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.

About the Areas to Be Discussed

  • Applicable Laws, Regulations and Definitions
  • Update on New Legislation, Current Trends and Impact
  • Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
  • CE Mark Process: CAs, NBs and EU Databases
  • Device Classification and Rules
  • Essential Requirements
  • Identifying Regulatory Requirements: Major Changes in 2014
  • How to Meet the Essential Requirements
  • Design Control
  • Verification and/or Validation
  • Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
  • EN ISO 13485:2012
  • ISO 14155
  • Quality Management Systems and Changes Effective for Own Brand Labelling
  • Label, Labeling, and National Requirements
  • Content and Format for a Technical File (STED)
  • Contents and Format for a Design Dossier
  • Integrating a Unique Device Identification (UDI) System with Improved Awareness
  • Good Practices: Tips and Suggestions for Unannounced Audits
  • Conclusion

About the Intended Attendee(s)

  • Regulatory Affairs
  • R & D
  • Clinical Affairs
  • Quality
  • Consultants
  • Marketing
  • Legal and Compliance Officers
  • Executive Management
  • Anyone Interested in the CE Marking Process

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. 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 recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS).  Dr. Lim also is an author for the RAPS’ online class for EU medical device regulations.  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