Virtual Classroom Training

Bespoke interactive e-learning

High-level introduction into mutual recognition and decentralized procedures. This training is designed for Pharmacist, Physicians and other functions (Regulatory Affairs, Development) better understand the European procedures of mutual and decentralized recognition. But anyone interested in the topic can register.

Date: October 19th, 2021

Type: Virtual Classroom Training

Duration: 1 Day

Who should attend?: Pharmacist, Physicians and other functions (Regulatory Affairs, Development) who want to better understand the centralized European procedure

High-level introduction into mutual recognition and decentralized procedures. The key learnings of this training are:

  • Implement the mutual and decentralized recognition procedures and applicable texts
  • Understand the deadlines imposed and the expectations of the authorities at each stage
  • Define a registration strategy taking into account the stakes

Laura BOTEANU-JOTZU

Laura has been involved in PharmaLex since 15 years, mainly in projects of centralized and decentralized European procedures for several pharmaceutical companies, both European and international; she manages and coordinates a European and international regulatory affairs team
Among Laura’s missions: proposal and implementation of a technical-regulatory strategy; professional relations and negotiation with health authorities for the registration and life cycle management. It defines, proposes, implements and develops the regulatory strategy based on legal constraints and according to the company’s R&D and commercial policies.
She also conducts awareness seminars in companies and universities on the importance of strategic issues related to European regulations.

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