2022-11-24 2022-11-24 , online online, 1.090,- € zzgl. MwSt. Cyril van Erp https://www.forum-institut.de/seminarDetail/636/referenten/22/22_11/22112454-online-course-pharma-project-management-in-regulatory-affairs_van-erp-cyril.jpg Project Management in Regulatory Affairs

Strategic and operational planning for efficient Marketing Authorisations - Take the chance and discuss your daily business challenges with our experts! The training course will be entirely held in English.

Topics
  • Project planning from preclinical testing to approval
  • Communication with national authorities and EMA/CHMP
  • Approval strategies in practice
  • Project management during MA and lifecycle management
  • PM at the interface preclinical, clinical and quality
Aims and objectives
This online seminar provides practical information on the essential project management tasks in Regulatory Affairs (RA) in Europe.

Both the regulatory strategy plan and the operational project and schedule from development to approval are addressed. Professional regulatory documents and optimal communication with the regulatory authorities also play an important role.

At the end of the seminar, you will have acquired regulatory know-how based on many case studies and practical exercises. You will be able to manage your projects more efficiently, both in development and in the approval process as well as postapproval.
Who should attend

This practical seminar is aimed at RA staff who accompany projects or manage them themselves.
The seminar also provides employees from related departments such as Medical Affairs or Development with starting points for efficient cooperation with RA.

The basic principles of drug approval in the EU are assumed to be known.

Online course - Pharma -  Management in Regulatory AffairsOnline course - Pharma - Project Management in Regulatory Affairs

Project Management in Regulatory Affairs

- Online training -

Benefits
  • First-hand information
  • Meet the experts
  • Submit your questions prior to the training
  • Interactive online format without travel expenses
  • We are following the IMI quality criteria

Webcode 22112454

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

24.11.2022

24.11.2022

Zeitraum

09:00 am - 5:30 pm - seminarYou may ...

09:00 am - 5:30 pm - seminar
You may dial in 30 minutes before the training starts.
Veranstaltungsort

online

online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

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

Details

Strategic and operational planning for efficient Marketing Authorisations - Take the chance and discuss your daily business challenges with our experts! The training course will be entirely held in English.

Topics
  • Project planning from preclinical testing to approval
  • Communication with national authorities and EMA/CHMP
  • Approval strategies in practice
  • Project management during MA and lifecycle management
  • PM at the interface preclinical, clinical and quality
Aims and objectives

This online seminar provides practical information on the essential project management tasks in Regulatory Affairs (RA) in Europe.

Both the regulatory strategy plan and the operational project and schedule from development to approval are addressed. Professional regulatory documents and optimal communication with the regulatory authorities also play an important role.

At the end of the seminar, you will have acquired regulatory know-how based on many case studies and practical exercises. You will be able to manage your projects more efficiently, both in development and in the approval process as well as postapproval.

Who should attend

This practical seminar is aimed at RA staff who accompany projects or manage them themselves.
The seminar also provides employees from related departments such as Medical Affairs or Development with starting points for efficient cooperation with RA.

The basic principles of drug approval in the EU are assumed to be known.

Detailed programme

09:00 am - 5:30 pm - seminar
You may dial in 30 minutes before the training starts.

09:00 Welcome and introduction round


09:15

Cyril van Erp

Project planning from preclinical testing to approval
  • Project planning with practical examples

10:00

Frank de Vries

Communication with national authorities and EMA/CHMP
  • Meetings with national authorities and/or EMA
  • When and with which questions?
  • Dealing with questions from authorities and deficiencies

11:00

Frank de Vries

Approval strategies in practice
  • The regulatory strategic plan:New vs. known substances
  • Decisions of the PRAC, referrals
  • Labelling strategies and their implementation
  • Consider HTA requirements at anearly stage!
Flexible short breaks à 5-7 minutes(15-20 min. in total) will be considered.

12:15 Lunch break


13:15

Frank de Vries

PM in the MA phase
  • From national to European approval: Which type of application when?
Time planning, submission modalities
  • Process of decentralised procedures (MRP, DCP): Where are the issues?
  • European phase and national phase
  • Special features for duplicate approvals, generic, repeat/well-established use, ...
  • Frequent errors by applicants
  • Use Scientific Advice and information from the authority
  • Drug approval in Europe: Current situation and influence of new regulatory requirements on the PM

14:15

N.N.

PM in lifecycle management
  • Renewal and variation management
  • Licensing features

15:30

Cyril van Erp

PM at the interface preclinical, clinical and quality
  • Scheduling of clinical trial reports
  • Coordination of service providers
  • Successful inspections in interface areas
Flexible short breaks à 5-7 minutes(15-20 min. in total) will be considered.

17:00 Summary and outstanding questions


17:30 End of online training


More information

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

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 b.wessels@forum-institut.de

In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.

This distinguishes our events

Overall score of all evaluations in 2021

Five stars on Trustpilot = Excellent

Recommendations

Multinational Clinical Trials of Medical Devices

Learn how to effectively organise multinational clinical trials for medical devices in the US, Europe and China in accor...

26. - 27.09.2022, Online
Details

CMC requirements in Latin America

CMC requirements in Latin America with focus Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and part...

21. - 22.09.2022, Online
Details

eSubmission Management in Europe

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity f...

30. - 31.08.2022, Online
Details
PharmaFORUM Webcast International "A company's QPPV Network"

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

01.09. - 31.08.2023, Online
Details
PharmaFORUM Webcast Biologics "Regulatory support in pharmaceutical development - exchange with regulators from Bench to Bedside"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulator...

01.09. - 31.08.2023, Online
Details

Go forward

DEMO-Account

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

Details
DEMO Account
Seminar program

Here you can find the seminar program of the next months.

Details
Seminar program
Quality guaranteed!

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

Details
More on our quality criteria