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ONLINE TRAINING: eSubmission, Update on all Telematics Projects and the Impact on Regulatory Processes and Companies

Get informed about the latest status of all EU projects on electronic submission, ranging from eCTD, eAF, CESP, xEVMPD, SPOR, ISO IDMP and ePI

Date

20-22-27 October 2020

Location

Online

Language

English

ONLINE TRAINING: eSubmission, Update on all Telematics Projects and the Impact on Regulatory Processes and Companies

It is a challenge to keep up-to-date with the details of the EU Regulatory Telematics environment. Besides electronic Common Technical Document (eCTD), many other eSubmission projects are ongoing, including: electronic Application Form (eAF), Common European Submission Plaform (CESP), the EMA Gateway, eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD), ISO Identification of a Medicinal Product (IDMP), SPOR Master Data Management project and electronic Product Information (ePI).

This course will explain the history, current state and outlook of these Telematics projects and impact on Industry. Moreover, it will provide insight on the latest developments, from direct interactions with EMA and National Competent Authorities (NCAs).With all these developments and ongoing activities, this course becomes a 3x3 hour online class and bring you up-to-date with all you need to know with regards to the roadmap and strategy of eSubmission and what you have to consider from an organizational point of view for your company. If you're responsible for Regulatory Affairs, you might not have the time or resources to be aware of all developments, changes and update on the Telematics roadmap and impact on processes within your organization. To get up-to-date, this course will put the attention on what are the issues to think about for getting ready, including possible Regulatory Information Management (RIM) solutions and company requirements.

Module 1 : EU Telematics strategy

Module 2 : Dossier preparation 

  • eCTD
  • Submission (EAF, CESP and Gateway)

Module 3: Regulatory Information Management

  • xEVMPD
  • SPOR 
  • ISO IDMP


Course language

The course will be in English
Remco Munnik
Remco Munnik Associate Director at Iperion, The Netherlands

Remco has a Bachelor degree in Business Administration (Management, Economics and Law). He has over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission and regulatory data management. He has been directly involved in the development and roll-out of the EU Telematics environ¬ment and has in-depth knowledge of the systems. Key areas of expertise include Regula¬tory submissions (new MAA to variations), Global eCTD submission, Regulatory Information Management systems (RIM), xEVMPD, ISO IDMP.

Regulatory Affairs, Regulatory Operations, IT responsible, Pharmacovigilance


Participant experience

At least 1-2 years’ experience in Regulatory Affairs and/or Regulatory Operations.

Interactive training on the latest eSubmission projects to create the effective telematics roadmap

Online interactive training on Zoom platform. 

Online training - 3 modules

October 20th, 2020             2.30 pm - 5.30 pm CEST
October 22nd, 2020            2.30 pm - 5.30 pm CEST
October 27th, 2020             2.30 pm - 5.30 pm CEST


After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Certificate of attendance

Early Bird: € 1.320,00* (until 29 September 2020)

Ordinary: € 1.420,00*

Freelance - Academy - Public Administration**: € 792,00*


*
for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

1420.00 €

Early Bird

Tuesday, September 29, 2020

1320.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

3 modules, 3 hours each

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Understand the current state, latest developments and the future in Telematics area.

  • Assess the impact the eSubmission roadmap has on your organization

  • Prepare yourself and your company for the (near) future, eSubmission requirements

Participants' Feedbacks

International and multidisciplinary profile of participants, which enriches the training

Exemples from real life situations from the workplace were very useful.

Excellent interaction between teachers and participants

no standard workshop which is very stressful so the way that this course was conducted was excellent and the first one for me were I was so relaxed… thank you for that feeling!

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

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ONLINE TRAINING: eSubmission, Update on all Telematics Projects and the Impact on Regulatory Processes and Companies

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
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SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.