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Event Details


How to Prepare the Marketing Authorization in Europe 2018

Marketing Authorization in Europe

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Who should attend?

Regulatory Affairs personnel involved in Development of medicinal products



In this seminar, we will look into all elements of the MAA dossier, in particular module 1, and within this module the Product Information. In addition, the various meetings with the Health Authorities in the centralized procedure will be discussed.

Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.

The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easy-to-read format for patients.

The SmPC provides the basis of information for healthcare professionals to use a medicine safely, effectively and in the most appropriate manner. It is also a legal document, agreed between the Authorities and the relevant pharmaceutical company.

The format and content of the SmPC is laid down in EU/national legislation and regulatory guidance documents. Use of a medicine outside the conditions/ recommendations described in the SmPC falls under the responsibility of the healthcare professional.


Why should you attend:

This seminar is specifically designed for personnel that will have to prepare a Marketing Authorisation Application in the EU. It is important to do this correctly, as otherwise the application may be rejected at validation (at the time of submission) or there may be delays later in the process


Areas Covered in the Session:


  • SmPC
  • Package Leaflet
  • Labelling
  • Readability testing
  • How to conduct presubmission meetings with the EMA and Rapporteurs


Who will benefit:

  • Regulatory Affairs personnel involved in Development of medicinal products

Location:  Zurich, Switzerland Date : April 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50




Register now and save $200. (Early Bird)

Price: $1,695.00 (Seminar Fee for One Delegate)

Until March 10, Early Bird Price: $1,695.00 From March 11 to April 16, Regular Price: $1,895.00

Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

Register for 10 attendees   Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661



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Register now and save $200. (Early Bird) Price: $1,695.00 (Seminar Fee for One Delegate) Until March 10, Early Bird Price: $1,695.00 From March 11 to April 16, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*


John Robinson

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