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MARKETING APPROVAL of MEDICINAL PRODUCTS: Regulatory procedures & applications

7 decembrie 2020 @ 8:00 am - 8 decembrie 2020 @ 5:00 pm

This training is part of an online series of Regulatory courses, designed to gradually present, in a professional but flexible environment, some of the Essential Skills of a Regulatory Affairs Professional:

Regulatory Technical knowledge: Regulatory procedures & applications

  • Centralized MAA – Scope and eligibility, Pre-submission activities, Submission timelines, CHMP opinion, Accelerated assessment, Linguistic review
  • Orphan designation EU – Benefits/incentives or Orphan legislation, Application, Maintenance before MAA
  • Paediatrics – Benefits/incentives of Paediatric Regulation, PIPs and modifications, Details of application process
  • DCP Procedure for registration and maintenance during the life cycle of medicinal products – Scope, eligibility/applicability, EU Applicable Legislative framework
  • Documentation structure and regulatory requirements or different registration application types; Well-established use
  • CTD file structure; Non-clinical overview Module 2 preparation

Soft skills: Negotiation

  • Negotiation skills – Negotiation checklist, Variables in negotiations, Trading positions, Motivation and personal power, Rules of trading, Difficult Negotiators
  • Negotiating skills – customised interactive workshop for Regulatory Affairs professionals (collecting questionnaire responses)


This course is intended for regulatory affairs staff (beginners and experienced) who are willing to progress in own career path, exchange knowledge and experience with peers, and build a personal network.


All topics are including theoretical knowledge and practical-real experience of the speakers, as recognised experts in European pharmaceutical area:
Jana Brajdih Čendak, Katja Pečjak, Anna Somuyiwa, Peter Kreft, Elena Georgescu


This training is designed to facilitate flexible participation of trainees, in line with their professional needs, program availability, existing level of expertise.

Course is structured in 4 stand-alone but interconnected sessions. Trainees may attend and purchase the full course or individual sessions.

For enrolling, please download, complete, sign the Registration Form and send it to


Topics are customised for fulfilling educational needs for entry and respectively advanced level of Regulatory Affairs expertise of trainees. Each of two training days are divided in 2 sessions, morning sessions setting the stage for the more advanced and interactive afternoon sessions.


For more details, please download available course Agenda.

Speakers are recognised experts in European pharmaceutical area. Jana Brajdih Čendak – Medical Doctor, Medical Faculty of the University of Ljubljana, Slovenia
Has experience in Gx and innovative pharma area; Involved in preparing expert opinions, clinical and non-clinical documentation for registration processes and for performing medical evaluations of adverse events and safety signals; Acts as a Medical Writer involved in clinical development planning at various phases; An active member of EMWA, leading the Compliance workstream at Medicines for Europe and as a member of the Pharmacovigilance, RMP, safety signals and PSUR workstreams; Has a specialty as a clinical expert opinion and clinical trials planning and designing; Works on Environment risk assessments for the purpose of marketing authorization applications; Certified GCP Auditor

Anna Somuyiwa – BSc in Pharmacology with Management from King’s College, University of London, and a Postgraduate Diploma in Regulatory Affairs from the University of Wales. Certified in DISC personality assessment and coaching/mentoring.

Has over 15 years’ experience specializing in regulatory affairs, including product development, registration, and commercialization phases for pharmaceutical and biotechnology companies, as well as Clinical Research Organizations; Her focus is on interactions with the European Medicines Agency (EMA) and its committees and to obtain and maintain Centralized product license for a variety of therapeutic areas; Has led several project teams in the delivery of complex regulatory strategies and submissions, which have included MAA via CP, registration strategies for a new pediatric indication and maintenance of several Orphan products, as well as several registrations for Generics products via the Decentralized and Mutual Recognition procedures; She has been involved in developing a regulatory strategy for product expansion, and leading development of a global dossier to supporting international Marketing Applications.

Katja Pečjak – M.Sc. Pharmacy – Medical Faculty of the University of Ljubljana, Slovenia

Extensive experience in Pharma and Veterinary pharmaceutical area; Experienced in regulatory affairs and pharmacovigilance; Leadership role of professional expert teams, as a manager and Head of the regulatory affairs department; Currently acts as a Director of Regulatory Affairs and EU-QPPV; Interacting with all European Competent Authorities; Experience in regulatory affairs of human medicinal products, regulatory strategies, electronic submissions, profound knowledge about DCP procedures as a leading contact person to the RMS and CMSs, including building the strategy and documents management.

Peter Kreft – Psychologist, MSc Organizational Development University of Salford; PD & OD Consultant

Is an independent consultant, specialized in the field of people and organizational development; For more than 20 years he has worked within and with pharmaceutical industry, helping people develop their potential; He has worked as a trainer and coach with marketing, sales, human resources, medical, regulatory affairs, with managers and experts, and has also carried out trainings for medical doctors. His trainings are practical, tailor made, aligned with participants ‘wishes and needs; holds a BA degree in psychology and an MSc in People and Organizational Development; During his career he has gained valuable knowledge and experience throughout Europe, North America, Africa and Asia.

Elena Georgescu – Pharmacist, Pharmacy Faculty of the University of Bucharest, Romania

Over 2 decades experience in pharma industry, including multinational arena, in different GxP technical roles, coordinating and executing various local and global projects.; Recognized pharma professional freelancer expert with expertise in various GxP technical areas (regulatory affairs, pharmacovigilance, clinical trials, quality assurance, FMD); Certified ISO 9001, 13485 auditor;




7 decembrie 2020 @ 8:00 am
Se termină:
8 decembrie 2020 @ 5:00 pm
Eveniment Category:

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