LIVE Online Seminar | Regulatory Requirements for Generic Medicines in US, EU and Canada
Title: Overview of the Regulatory Requirements for Generic Medicines in US, EU and Canada
- Date: this seminar recurrs tri-monthly on fourth (4th) Fridays – when you register, you will be registering for the next upcoming seminar.
- Time: 01:00 PM PST | 04:00 PM EST
- Duration: 60 Minutes
- Product Code: GCS14-105
About the Seminar
This seminar is intended to present an overview of the regulatory requirements for generic medicines in US, EU and Canada.
The speaker will present applicable laws and regulations for generic medicines in US, EU and Canada. In particular, the regulatory requirements to obtain regulatory approvals for generic medicines for human use will be presented in a CAC-SI manner.
*: CAC-SI refers to current, accurate and comprehensive/complete in a systematic, integrated manner.
In this 60-min presentation, the speaker will guide you through the details of the requirements to obtain generic marketing approvals in US, EU and Canada.
About the Areas to Be Discussed
- Applicable laws and regulations in US, EU and Canada
- Applicable guidelines
- Marketing authorization process in US, EU and Canada
- Regulatory requirements in US FDA, EU EMA and Health Canada
- Good manufacturing practices
- Key issues
- Speaker’s practical, actionable and sustainable solutions
- 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
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 use compliant with e-Copy and RTA policy. Dr. Lim also developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past 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.
Note: when you register, you will be registering for the next upcoming seminar.
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- LIVE (one attendee): $199
- Recorded: $249
- LIVE (≤ 5 attendees): $599
- LIVE (≥ 6 attendees): $999
- LIVE & Recorded: $299