European Medicines Agency 

Centralised procedure; application, responses, strategic options, precedence

Preparation for Oral Hearing for CVMP, training and guidance

Scientific advice requests for predictability of acceptance

Referrals; planning responses, scientific writing

Re-examination of Negative Opinion

List of Questions; writing responses, assess adequacy

EMA contacts, questions, product classification

New product development

Regulatory review of novel therapies or new concepts

Gap analysis of data for marketing authorisation applications

Product development plans (safety + efficacy); pharmaceuticals, biologicals, vaccines.

Novel therapies;

gene technology,

DNA-vaccines,

stem cell products

Review of clinical trial protocols, VICH GCP

Clarify MRL-status for active ingredients or excipients ('allowed substance') and your options

Regulatory science EU

Expert reports (DACS) for safety and efficacy of pharmaceuticals, biologicals, vaccines

SPC harmonisation

Limited Market – Minor Use Minor Species – classification, Reg. 2019/6 §4/ §23, guidelines for reduced data requirements

Regulatory classification of biologicals; immunological vs non-immunological

New veterinary medicines EU Regulation 2019/6, applicable from 28/1 2022

Board positions

Open for positions in Management board / Board of directors

Experience as CEO, stock market registration (IPO), management board sparring

Advisory board experience

Leading scientific groups

Chairing of scientific groups

Management of project groups

Progressing and participation in drafting groups

Scientific writing

Courses in regulatory science topics

Scientific writing, including articles for publication

Conference conclusions or minutes.