When:
December 11, 2017 @ 11:00 AM – 12:00 PM
2017-12-11T11:00:00-05:00
2017-12-11T12:00:00-05:00
Where:
Online
Cost:
$199
Contact:
Global compliance Seminar
731-Go to GCS (468-6427)

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 
Overview of the EMA Marketing Authorization Applications for Medicinal Products
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