2023-01-30 2023-01-30 , online online, 1,190 € plus tax Dr. Ulrich Granzer https://www.forum-institut.com/seminar/23022610-regulatory-affairs-in-the-us/referenten/23/23_02/23022610-course-pharma-regulatory-affairs-in-the-us_granzer-ulrich.jpg Regulatory Affairs in the US

Meet the experts Dr Ulrich Granzer and Dr Scott Oglesby and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!

Topics
  • Drug regulation in the USA
  • The IND, NDA and BLA procedures
  • Communication with the FDA
  • Life cycle: changes following approval of NDAs and BLAs
  • Interactive workshop session: Participants are invited to submit individual cases prior to the event
Aims and objectives
The purpose of this course is to provide an overview of the regulatory environment for new drug approvals in the US.

The course aims to:
  • familiarise participants with the requirements for FDA approval of a medicine for the US market;
  • give insight into the different development pathways;
  • provide guidance on how to interact with the FDA;
  • explain the differences between the US and EU approval processes.

Take the opportunity to meet our experts Dr Granzer and Dr Oglesby and get first-hand information, suggestions and tips for daily business challenges.
Who should attend

This course meets the needs of all those in the pharmaceutical industry who are involved in new applications and wish to develop their knowledge of the US regulatory environment, as well as of those in associated industries who wish to gain a comprehensive understanding of the subject.

Course - Regulatory Affairs in the US

Regulatory Affairs in the US

Benefits
  • Meet the experts!
  • First-hand information
  • Experts with local know-how
  • Provide your individual questions beforehand
  • We are following the IMI quality criteria

Webcode 23022610

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

28/02/-01/03/2023

28/02/-01/03/2023

Period

Both days from 14:00 - 18:00You may ...

Both days from 14:00 - 18:00
You may dial in 30 min. before the session
Venue

online

online

Fee
Your contact

Dr. Tatjana Mende
Conference Manager

+49 6221 500-565
t.mende@forum-institut.de

Details

Meet the experts Dr Ulrich Granzer and Dr Scott Oglesby and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!

Topics
  • Drug regulation in the USA
  • The IND, NDA and BLA procedures
  • Communication with the FDA
  • Life cycle: changes following approval of NDAs and BLAs
  • Interactive workshop session: Participants are invited to submit individual cases prior to the event
Aims and objectives

The purpose of this course is to provide an overview of the regulatory environment for new drug approvals in the US.

The course aims to:

  • familiarise participants with the requirements for FDA approval of a medicine for the US market;
  • give insight into the different development pathways;
  • provide guidance on how to interact with the FDA;
  • explain the differences between the US and EU approval processes.

Take the opportunity to meet our experts Dr Granzer and Dr Oglesby and get first-hand information, suggestions and tips for daily business challenges.

Who should attend

This course meets the needs of all those in the pharmaceutical industry who are involved in new applications and wish to develop their knowledge of the US regulatory environment, as well as of those in associated industries who wish to gain a comprehensive understanding of the subject.

Detailed programme

Both days from 14:00 - 18:00
You may dial in 30 min. before the session

14:15

Drug regulation in the USA
  • Role, duties and responsibilities of the FDA: CBER, CDER, ...
  • FDARA, PDUFA VI, UFAs
  • Current developments

14:45

The IND (Investigational New Drug) procedure
  • Are clinical trials in the US mandatory?
  • Main features and differences for the compilation of an IND and an IMPD
  • Practical experiences
  • Avoiding typical mistakes

16:00 Coffee break


16:15

The NDA (New Drug Application) and BLA (Biological License Application) procedure
  • Dossier requirements
  • ANDA procedure
  • Drug master files
  • When to file an NDA and when an BLA?
  • Practical experiences
  • Avoiding typical mistakes

17:45 Summary and outstanding questions


18:00 End of training day I


14:00

Communication with the FDA
  • Meeting types: pre-IND meeting, end of phase II, pre-submission, advisory committee meetings, etc.
  • Planning and conducting FDA meetings
  • Starting the communication: meeting agenda

15:15 Coffee break


15:30

Workshop
Participants will form small groups to work on a single task such as preparing a briefing book, analysing a deficiency letter, or addressing an individual case. The results will then be discussed in the plenum.

16:30

The marketing authorisation has been granted: What's next?
  • Maintenance of INDs, NAD, BLA
  • Reporting obligations
  • Annual report
  • Dossier changes
  • Practical experiences
  • Avoiding typical mistakes

17:45 Summary and outstanding questions


18:00 Seminar end


More information

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to t.mende@forum-institut.de

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

This distinguishes our events

Overall score of all evaluations in 2022

Five stars on Trustpilot = Excellent

Recommendations

The EU Qualified Person for Pharmacovigilance (EU-QPPV)

Update your knowledge: Our team of experts provides you with important and practical information about the tasks and res...

06.02.2023, Online
Details
Clinical Trials in a Nutshell: The European Regulatory Framework

All the essentials of clinical trials in Europe in only two days! Six experts will share their in-depth knowledge with y...

23. - 24.03.2023, Online
Details

Market Access in Germany, Austria and Switzerland

HTA and reimbursement in Austria, Switzerland and Germany - hands- on experiences guaranteed

24.02.2023, Online
Details

PharmaFORUM Webcast International

Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...

01.11. - 31.10.2024, Online
Details

e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

31.12.2023, Online
Details

Go forward

Our international course portfolio

We provide a variety of international courses for the healthcare industry.

Details
International seminars
DEMO-Account e-Learning

Try out our e-Learning programmes free of charge and without any obligation.

Details
DEMO-Account e-Learning
Quality guaranteed

Your feedback produced as result of 1.8 in 2021. Thank you!

Details
More on our quality criteria