People

Doris Weber Rüegger

DAS Pharmaceutical Medicine
MSc Biomedical Engineering
Chemist FH

Since 2014 Owner and director of PHARCONS Pharma Consulting GmbH:
- Services in pharmaceutical RA-, Quality- and PV-Area at Swiss SMEs as well as at Swiss subsidiaries of international companies.
- Assumption of various functions (responsible person for handling controlled substances, FvP as well as qualified person for pharmacovigilance), both interim and long-term.
- Management, Establishment and maintenance of the company and the costumer relations.
Long-time, profound experience in the pharmaceutical field as employee in Swiss affiliates of international pharmaceutical companies as well as in an international consultancy company.
Head of laboratory (inclusive personnel management) in a service laboratory for microbiology.
Medical laboratory technician (microbiology, food safety, clinical chemistry, haematology, immune haematology, pathology).
Languages: German and English (fluent in written and spoken), French and Italian (technical vocabulary).

CAS Quality Manager Pharma
Certified technical expert HF corporate processes
Certified food technologist HFP

Quality and Regulatory Affairs Manager at PHARCONS Pharma Consulting GmbH.
CAS Quality Manager Pharma at University of Applied Sciences and Arts Northwestern Switzerland.
Experience in the pharmaceutical area:
- Quality: Market releases, self-inspections, external audits, revision and creation of SOPs, PQR review, support in the devel-opment and maintenance of QM systems, employee training in the quality area, FvP Stv, QA in production.
- Regulatory: Life-Cycle Management (incl. authorisation extensions, variations (all types), PSUR, renewal, labeling changes), eCTD, etc.
Education in the food industry with a higher technical examination as a certified food technologist HFP and as a certified technical expert HF corporate processes.
Languages: German and English (fluent in written and spoken).

Federally Certified Pharmacist FPH
MSc ETH Pharmaceutical Sciences

Regulatory Affairs Manager at Pharcons Pharma Consulting GmbH.
Professional experience:
- RA: Management hematology portfolio including life-cycle management, PSURs, label change requests (i.e. address change of marketing authorization holder), promotional material review, CPPs; marketing authorization applications (i.e. biosimilars), extension applications (i.e. indication extensions) regular and article 13 procedures TPA, orphan drug status application, co-lead cross-functional meetings.
- Quality Affairs: PQR Review, document management (i.e. electronic storage, inventory, creation of batch record templates), processing of returned goods.
- Pharmacist: Experience as permanent floater pharmacist and permanent employee; with management responsibility at the current working day; advising customers regarding intake and use of medication and treatment of symptoms and mild diseases, selling of medicinal products, services (i.e. measuring of blood pressure, heart check, etc.), production of medicinal products (i.e. ointments, solutions, etc.), first contact person in case of medical emergencies in immediate surroundings.
Engagement: Experience as board member in diverse student associations (president, vice president, culture minister, member of individual event committees).
Languages: German, Portuguese, English, French and Spanish (fluent in written and spoken), Italian (technical vocabulary).