Course Language: English 08:30-18:00 For additional information: +39 (0)35.515684 210 € Early Bird discount for enrolment by 09/04/2020 www.LSacademy.com [email protected] Thursday 07 and Friday 08 May 2020 Update on Regulatory Affairs developments in Europe and the impact on product development and life cycle management Advanced European Regulatory Affairs The Netherlands Amsterdam Il Vaso di Fiori Taking part in our training courses, you support "The Vase of Flowers" project 07 - 08 May 2020 - Amsterdam
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Course Language: English
08:30-18:00
For additional information: +39 (0)35.515684
210 € Early Bird discount for enrolment by 09/04/2020
Thursday 07 and Friday 08 May 2020
Update on Regulatory Affairs developments in Europe and the impact
on product development and life cycle management
Advanced European Regulatory Affairs
The Netherlands
Amsterdam
Il Vaso di FioriMichela Rimondini e Monia Dardi
Taking part in our training courses, you support "The Vase of Flowers" project
07 - 08 May 2020 - Amsterdam
Introduction
During this regulatory affairs course 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.
To whom it may concern
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.
www.LSacademy.com
Advanced European Regulatory Affairs
07 - 08 May 2020 - Amsterdam
Type of Training
Presentations, including practical sessions of business cases and questions from audience.
Course Language
The course will be in English
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Course Language: EnglishProgramme
Review of the European Regulatory Affairs legislation
• Managing strategies based on European Regulatory Affairs
• Understanding the new regulatory procedures - What’s new in Regulatory Affairs?
o PRIME / adaptive licensing
o Falsified Medicine Directive and impact on Regulatory Affairs
o Brexit
• EU procedures, CMDh guidance and Q&A documents:
o National / MRP/ DCP / CP
o Variations
o Renewals
• Advanced Regulatory Affairs in EU:
o Orphan Drug Designation
o Pediatric Investigation Plans
o Scientific Advice / protocol assistance
o IMPD / IB
o ATMPs: Cells, tissues, organs, gene therapy, cloning
o Biosimilars
• Electronic Submission in EU
o Future projects, including review of strategy document
o eCTD
o CESP / Gateway
o xEVMPD / ISO IDMP
Advanced European Regulatory Affairs
Agenda
8:30 - 9:00
9:00
10:45 - 11:00
13:00
16:15 - 16:30
18:00
Day 1
Course commences
Coffee Break
Lunch
Coffee Break
Q&A and Conclusion
8:30
10:15 - 10:30
12:30
15:00 - 15:15
16:30
Day 2
Participants registration
Course commences
Coffee Break
Lunch
Coffee Break
End of day 1
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www.LSacademy.itwww.LSacademy.com
LecturersLidia 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 whi-
ch 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, 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 environment
and has in-depth knowledge of the systems. Key areas of expertise include Regulatory sub-
missions (new MAA to variations), Global eCTD submission, Regulatory Information Mana-
gement systems (RIM), xEVMPD; ISO IDMP
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.
Advanced European Regulatory Affairs
Participant experience
Participants need to have a basic understanding of EU regulatory procedures.
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TO REGISTER FOR THE COURSE YOU CAN FILL IN AND SEND THE REGISTRATION FORM
OR DIRECTLY REGISTER ONLINE
Early bird: € 1670,00* until 09/04/2020
Ordinary: € 1880,00*
Freelance – Academy – Public Administration**: € 990,00*
*For Italian companies: + 22% VAT
The fee includes: tuition, teaching materials, lunches and coffee breaks,
organizational office assistance, attendance certificate.
Methods of payment
EasyB S.r.l. Via Roma, 20 - 24022 Alzano Lombardo (BG)
P. IVA 03633040161
Banco BPM - Filiale di Carobbio Degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT CODE: BAPPIT21AY5
The full amount must be paid on registration to EasyB s.r.l
by bank transfer or by credit card. If paying by bank transfer
please attach proof of payment to the registration form.
Bank transfer payable to:
Terms & conditions
Please fill in and send: (+39) 035.4501262
Date SignatureLSACADEMY.com
Terms of payment The registration fee must be paid at the time of registration. Confirmation of course admission will be given on receipt of payment. EasyB reserves the right to refuse late
registrations or additional registrations above the maximum accepted number of participants.
Cancellation Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the course date. Cancellations will only be valid if made in writing. Transfer
of registrations (or name changes) are allowed 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 adver-
tised speakers for an event. 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, or hostilities. LS Academy reserves the right not to accept registrations not compatible with the event’s target audience.
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.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), 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.
Company name
Address
Mail address (If different)
City
VAT number
Invoicing details
Surname
Company
Address
City
Tel.
Special Dietary Requests
Name
Job title
Post code
Fax.
Post code
Invoice recipient code
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
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REGISTRATION FEES:
Advanced European Regulatory Affairs
07 - 08 May 2020 - Amsterdam
Per info contattare:
Segreteria Organizzativa Mara Algarotti +39 (0)35.515684 [email protected]
Segreteria Scientifica Valeria Quintily +39 329.4683329 [email protected]
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