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ONLINE TRAINING: Advanced European Regulatory Affairs

Update on Regulatory Affairs developments in Europe and the impact on product development and life cycle management

Date

30 September, 2-7-9 October 2020

Location

Online

Language

English

ONLINE TRAINING: Advanced European Regulatory Affairs

During this regulatory affairs online training, you will get an advanced introduction and insight into the challenging environment of EU regulatory legislation and a practical advice for future regulatory affairs projects. In addition, an update on the latest developments and impact on the daily activities of a pharmaceutical company will be provided. As a result of the training you should be able to avoid pitfalls and compliance issues with the latest European regulations and optimize the effectiveness of your Pharmacovigilance system.

MODULE 1 by Lidia Canovas - 30 September

 Understanding the new regulatory procedures – What’s new in Regulatory Affairs? 

  • Expedited Pathways: What happened during Covid-19 emergency?
  • Falsified Medicine Directive and impact on Regulatory Affairs
  • Brexit


MODULE 2 by Lidia Canovas - 2 October

EU Procedures, CMDh guidance and Q&A documents (2 hours)

  • National Procedure/MRP/DCP/CP
  • Variations and Renewals


MODULE 3  by Remco Munnik - 7 October

Electronic Submission in EU 

Current and future Telematics program and in-sight in the background and current status on ongoing projects:

  • Telematics strategy 2021-2025
  • eCTD
  • CESP/Gateway
  • eAF
  • xEVMPD
  • ISO IDMP
  • ePI


MODULE 4 by Lidia Canovas - 9 October

Advanced Regulatory Affairs in EU 

  • Orphan Drug Designation
  • Pediatric Investigation Plans
  • Scientific Advice / Protocol Assistance
  • IMPD and IB
  • ATMPS: cells, tissue, organs, gene therapy, cloning
  • Biosimilars

Review of the European Regulatory Affairs legislation

  • Managing strategies based on European Regulatory Affairs


Course Language

The course will be in English

Lidia Canovas
Lidia Canovas Director of Regulatory Affairs at Asphalion S.L.

Lidia has a Pharmacy and MBA degree.
She has more than fifteen years overall experience in pharmaceutical industry, most of which as Regulatory Affairs Director, but she has also covered the role of Vice-Director for Research and Development. She has worked at Asphalion for ten years as General Manager and Director of Regulatory Affairs. In this second role, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.

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.

The course is addressed to Regulatory Affairs Manager, Officer and Specialist, Quality Manager, Development Pharmacist, Pharmacovigilance Manager, Project Manager working for pharmaceutical companies and CROs.


Attendees’ experience

Participants need to have a basic understanding of EU regulatory procedures.

Presentations, including practical sessions of business cases and questions from audience.

Online training

This Online Training in divided in 4 modules:

- Module 1 | 30 September 2020 from 9.30 to 12.30 CEST

- Module 2 | 2 October 2020 from 9.30 pm to 12.00 CEST

- Module 3 | 7 October 2020 from 9.30 pm to 12.30 CEST

- Module 4 | 9 October 2020 from 9.30 pm to 12.30 CEST


The fee includes

Access to the Online Course, teaching materials in pdf format provided post-training, organizational office support, certificate of attendance.


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 09 September 2020)

Ordinary: € 1.490,00*

Freelance - Academy - Public Administration**: € 780,00*


*
for Italian companies: +22% VAT

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

The fee includes: Access to the online training, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.

Register now

Course Price

1490.00 €

Early Bird

Wednesday, September 9, 2020

1320.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

4 modules of 2,5 or 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 complex EU legislation and requirements and increase your knowledge of the latest developments in order to ensure future compliance

Participants' Feedbacks

Excellent interaction between teachers and participants

International and multidisciplinary profile of participants, which enriches the training

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

Good atmosphere in the group and interaction with the lecturers (really available for all questions)

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: Advanced European Regulatory Affairs

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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
IBAN: IT81 F 05034 53960 000000003450
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).

Information collection and use
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) 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 sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.