Course overview
This course investigates the how, what, and why of the USA Regulatory Framework. It is an advanced course that will help you understand the key role of the FDA and its division as well as help you identify the different types of applications for registration of product in USA. In addition, you will get an overview of pharmacovigilance, labelling and advertising requirements and become aware of process of communicating with FDA.
Outline
- History of drug regulation in the USA
- Overview of the FDA and structure
- Basis of regulatory affairs in the USA
- Types of applications
- The IND, NDA and BLA
- The ANDA and sNDA/sANDA
- Communicating with the FDA
- Pharmacovigilance
- Labelling and advertising
- Hot topics in the USA
Learning objectives
- After attending this course, participants should be able to:
- Describe how the USA pharmaceutical regulatory system operates including a top-level overview of the FDA structure
- Identify the different application types in USA (including IND, NDA, BLA, ANDA. sNDA and sANDA)
- Discuss how sponsors interact with the FDA
- Summarise the current hot topics that impact the US regulatory environment
Speaker Bio
Nisha has extensive experience of 20 years and has demonstrated considerable expertise in the field of Regulatory Affairs, handled various market applications in US, EU, ASEAN nations and India. In India, Nisha was heading Corporate Regulatory Affairs Department for Pharma Solutions business group at Piramal Enterprises limited headquartered in Mumbai, India. She was in-charge of Formulations, API, Local FDA and artworks groups and her key role was devising regulatory strategy for all submissions, devising regulatory policy for the organisation and ensuring regulatory compliance during audits by Health Authorities. Under her leadership, the team achieved approvals for various submissions to US and EU of different dosage forms. She has successful track record of handling inspections by US and EU authorities. In Australia, she had briefly worked as Project Manager for Neo health OTC and in her current role at ARCS, is responsible for growing the educational offering for regulatory medicines and pharmacovigilance professionals. Nisha is a registered pharmacist (BPharm) from India and has an Executive MBA from IIM, Calcutta, one of the most reputed and globally recognised management institutions.
Who should attend
Regulatory affairs professionals involved in preparing global submissions and those interacting with USA colleagues.
Continuing Professional Development (CPD) points
Upon completion of this workshop, attendees will receive 7 CPD points
Entry criteria
This is an advanced course for those with up to 3 years’ experience in Regulatory Affairs or with a particular need to understand the USA regulatory framework. Understanding of CTD, drug development and clinical development is assumed. If you have any questions on your suitability for this course, do not hesitate to call the ARCS office on (02) 8905 0829.
Registration fees
ARCS member - $805
Non-member - $1285
Registration terms and conditions
Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.
Virtual classroom
- This workshop runs for one full day from 09:00-17:00 AEST
- Attendee requirements:
- Computer/laptop connected to power
- Good internet access (1Mbps or better – broadband recommended)
- A charged mobile phone and headphones (if using your phone for audio)
- Phone charger – given the event goes all day, you will need a way of charging your phone
- Headphones for computer audio (if using computer audio)
- A quiet room/space