2021-12-09 2022-11-10 , online online, 1.190,- € plus tax Dr. Andreas Bonertz https://www.forum-institut.com/seminar/22112452-annual-cmc-conference/referenten/22/22_11/22112452-online-conference-pharma-annual-cmc-conference-202223_bonertz-andreas.jpg Annual CMC Conference

Get your quality-related regulatory update 2022/23 here - Day I: Update from authorities and working parties, day II: Update CMC requirements in non-EU regions, as China, Japan, India, Brazil, Mexico, Russia/EAEU (experts with local know-how). Take the chance and discuss your current daily business challenges with our experts and your colleagues. Both days may be booked seperately!

Topics
  • Update from the Quality Working Party: Current topics
  • Nitrosamine and azido impurities: Current status and expectations
  • Revision ICH Q9: Quality Risk Management
  • Post-Approval Change Management Protocols
  • CMC requirements in non-EU regions, e.g. China, Japan, India, Brazil, etc.
Aims and objectives
Do you work in Regulatory Affairs/CMC or Quality Assurance?

Then you shouldn‘t miss out on this event. This conference will address very practical questions and provide strategic information on future CMC trends.
I very much look forward to seeing you online.
Kind regards
Dr Birgit Wessels
Conference Manager Pharma & Healthcare
Who should attend

This online-conference will be of interest to anyone working in the pharmaceutical industry and dealing with CMC issues. Those working in the following departments will particularly benefit from this event

  • Marketing Authorisation/Regulatory Affairs/CMC;
  • Quality Assurance/Quality Control/Analytics; and
  • Production.

Online conference pharma - Annual CMC Conference 2022/23

Annual CMC Conference

- Online conference -

Benefits
  • First-hand information
  • Both days may be booked separately
  • Different prespectives: Authorities vs. industry
  • Online conference without travel expenses
  • We are following the IMI quality criteria

Webcode 22112452

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

09. - 10.11.2022

09. - 10.11.2022

Period

Both days from 9:00 am - 5:00 pmYou ...

Both days from 9:00 am - 5:00 pm
You may dial in 30 minutes in advance
Venue

online

online

Downloads
Fee
Your contact person

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Get your quality-related regulatory update 2022/23 here - Day I: Update from authorities and working parties, day II: Update CMC requirements in non-EU regions, as China, Japan, India, Brazil, Mexico, Russia/EAEU (experts with local know-how). Take the chance and discuss your current daily business challenges with our experts and your colleagues. Both days may be booked seperately!

Topics
  • Update from the Quality Working Party: Current topics
  • Nitrosamine and azido impurities: Current status and expectations
  • Revision ICH Q9: Quality Risk Management
  • Post-Approval Change Management Protocols
  • CMC requirements in non-EU regions, e.g. China, Japan, India, Brazil, etc.
Aims and objectives

Do you work in Regulatory Affairs/CMC or Quality Assurance?

Then you shouldn‘t miss out on this event. This conference will address very practical questions and provide strategic information on future CMC trends.
I very much look forward to seeing you online.
Kind regards
Dr Birgit Wessels
Conference Manager Pharma & Healthcare

Who should attend

This online-conference will be of interest to anyone working in the pharmaceutical industry and dealing with CMC issues. Those working in the following departments will particularly benefit from this event

  • Marketing Authorisation/Regulatory Affairs/CMC;
  • Quality Assurance/Quality Control/Analytics; and
  • Production.

Detailed programme

Both days from 9:00 am - 5:00 pm
You may dial in 30 minutes in advance

09:00

Andrew McMath (chair day one - confirmed)

Welcome and introduction

09:15

Dr Blanka Hirschlerová

Update from the Quality Working Party: Current topics in 2022/23
  • Which guidelines, recommendations, etc. are under review?

10:30 Coffee break and/or exchange with the experts "from bench to bedside"


11:00

Andrew McMath

Nitrosamine and azido impurities: Current status and expectations
  • Recap of the root cause
  • Actions taken by EDQM & Impact on the Ph Eur
  • Nitrosamines in all APIs
  • The lessons learned exercise: the different aspects including OMCLs

12:15 Lunch break


13:15

Dr Kevin O’Donnell

Revision ICH Q9: Quality Risk Management
  • Main changes and challenges
  • Implementation in the EU

14:30 Coffee break


15:00

Dr Andreas Bonertz

Post-approval change management protocols
  • PACMP: What it is and how it works
  • Benefits and drawbacks of PACMP
  • Strategies to consider

16:30 Summary and outstanding questions


17:00 End of conference day one


09:00

Dr Birgit Wessels (chair day two)

Welcome

09:15

Jack Wong

CMC requirements in China
  • Requirements in non-EU countries
    • Additional quality data to be generated
    • Documentation to be included in the dossier in context of CTA, MAA/BLA and postapproval changes
    • Practical experiences from industry perspective

10:15 Coffee break and/or exchange with the experts "from bench to bedside"


10:30

Dr Mohamed Oubihi

CMC requirements in Japan
  • General requirements and considerations
  • Stability and shelf life specifications
  • Japanese master file
  • Foreign manufacturer accreditation
  • Presentation of the data in Module 2

11:30

Pooja Maingi

CMC requirements in India
  • General requirements and additional quality data to be generated
  • Documentation to be included in the dossier in context of CTA, MAA/BLA and postapproval changes
  • Practical experiences from industry perspective

12:30 Lunch break


13:30

Dr Galina Senchukova

CMC requirements in Russia and EAEU
  • General requirements and additional quality data to be generated
  • Documentation to be included in the dossier in context of CTA, MAA/BLA and postapproval changes
  • Practical experiences from industry perspective

14:30 Coffee break


14:45

Ana Terra Dos Santos Macedo

CMC requirements in Brasil
  • General requirements and additional quality data to be generated
  • Documentation to be included in the dossier in context of CTA, MAA/BLA and postapproval changes
  • Practical experiences from industry perspective

15:45

Estefanny K Da Silva Neves

CMC requirements in Mexico
  • General requirements and additional quality data to be generated
  • Documentation to be included in the dossier in context of CTA, MAA/BLA and postapproval changes
  • Practical experiences from industry perspective

16:45 Summary and outstanding questions


17:00 End of conference


More information

Your benefits

  • CMC experts from the industry and from international authorities share their expertise with you
  • Advanced practical information will be obtained
  • Issues beyond your own specific area will be addressed
  • Online-conference in your office/homeoffice - no travel expenses, no loss of time

Individual questions

Please send us your questions concerning the conference 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 during the conference.
Please send your questions to: Dr. Birgit Wessels, b.wessels@forum-institut.de

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Overall score of all evaluations in 2021

Five stars on Trustpilot = Excellent

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