Soile ja Anu - Medimo.

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Personnel

Years of experience in the entire life cycle of the marketing authorisation process of medicinal products and especially knowledge of the local requirements in the Nordic countries guarantee the handling of regulatory affairs, pharmacovigilance and quality services with expertise.

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Anu Gummerus

The Founder of Medimo, Anu Gummerus, has more than 20 years of experience in working with tasks related to marketing authorisations, pharmacovigilance, and quality of medicinal products.

According to Anu’s motto, “the work is done well, right at once, but not as hairsplitter”.

Anu has graduated from Industrial Pharmacy in University of Helsinki as a Licentiate of Pharmacy. The topic of the licentiate thesis was ”The outsourcing of the regulatory affairs in the pharmaceutical industry”.

Anu has worked at the headquarters level of pharmaceutical companies as an EU QPPV. The most common dosage forms are medical gases, tablets, and sterile ophthalmic products. Anu is also experienced in writing and maintaining periodic safety update reports, risk management plans (RMP) and PSMFs. Anu has been establishing pharmacovigilance systems and performing practical pharmacovigilance tasks on behalf of the client. Anu has audited the pharmacovigilance systems of pharmaceutical companies and participated in authority inspections of pharmacovigilance systems at the customer’s request. Anu has completed EudraVigilance and XEVMPD certificates.

Anu also works as an auditor of pharmacovigilance systems. She has conducted internal audits, inter-company audits, and third-party audits. Anu has audited the pharmacovigilance systems of human and veterinary drugs.

Anu has participated in pharmaceutical product development projects from the beginning, advising on registration strategies in various marketing authorisation processes. Over the years, she has gained experience on the marketing authorisation procedures throughout the entire life cycle of medicines. In particular, the local marketing authorisation requirements of the Nordic countries are Anu’s know-how.

Anu has also worked as responsible director and quality pharmacist for pharmaceutical companies.

Anu’s absolute strength is a deep understanding of pharmacovigilance and marketing authorisation processes, as these two services are strongly connected in the marketing authorisation documentation of medicines, guaranteeing the safe and effective use of medicines.

Soile Hakala

Soile has almost 20 years’ experience of quality assurance in the pharmaceutical industry. The quality tasks in manufacturing of sterile products, raw materials and packaging materials are familiar to her. Soile has also experience of GMP/GDP training. Soile has audited several manufacturers (raw material, packaging materials, distributors, contract laboratories and contract manufacturers). She has been involved in manufacturing transfer projects as a quality representative. She has also acted as the Qualified Person (QP) of the contract manufacturers.

Soile has experience in setting up a quality system in a pharmaceutical industry and to ensure that all quality documentation meet GMP (Good Manufacturing Practice) and ISO 13485 requirements. Soile has been the responsible person (accountable director) of the pharmaceutical manufacturer and wholesale company.

Noora Rinne

Noora Rinne has been working in the global pharmacovigilance department in the pharmaceutical industry and as an authority in national agencies. Within pharmacovigilance, she has mainly been responsible for case reporting and her expertise is in operational pharmacovigilance. Noora is a pharmacist and toxicologist by education.

Noora’s work style is adaptable, and her work easily adapts to different work situations. In pharmacovigilance tasks, Noora finds it motivating to continuously review and promote the safety of medicines. The work allows her to use her expertise extensively and evolve through new challenges.

Hanna Hartikka

Hanna Hartikka has 10 years of experience in regulatory affairs within the pharmaceutical industry and in the parallel import of medicines. In addition to her role as a regulatory affairs specialist, Hanna has worked as a team leader of regulatory affairs professionals, and in tasks related to review of marketing materials, pharmacovigilance, and quality. Hanna holds a Bachelor’s degree in Pharmacy and a Master’s degree in Statistics.

Hanna has experience in reviewing educational and marketing materials, acting as a local pharmacovigilance contact person, conducting local literature searches in the Nordic countries, and preparing and updating product information texts. She has also been responsible for updating SOPs and drafting work instructions.

Hanna has participated in deviation and CAPA processes, inspections, and audits, and has been involved in drafting change controls and risk assessments.

Sanna Tuhkala

Sanna Tuhkala has several years of experience in the pharmaceutical industry as a Qualified Person, both in the roles of marketing authorization holder and contract manufacturer. Additionally, she has worked as a researcher in pharmaceutical development.

Sanna’s pharmaceutical industry experience includes sterile medicinal products and advanced therapy medicinal products (ATMP). She has QP experience with both types of products. She also has experience as the responsible person (accountable director) in pharmaceutical wholesale.

Sanna’s pharmaceutical industry experience is complemented by ten years of experience in a university hospital pharmacy. Her main responsibilities included supervising the cytotoxic drug reconstitution laboratory and handling clinical trial products. Her hospital pharmacy experience provided her with an understanding of GMP requirements in small-scale pharmaceutical manufacturing in a hospital pharmacy environment. The work involved preparation of standard operating procedures (SOPs) and training personnel in her area of expertise.

Sanna’s work approach is adaptable and positive. Her motto is that all problems can be solved, but quality must never be compromised.

Meri Tanner

Meri Tanner has diverse experience in the pharmaceutical field, covering the drug lifecycle from research to launch and beyond.

In recent years, she has applied and expanded this knowledge within the regulatory field, contributing to drug lifecycle management at a national competent authority. She has overseen the coordination and assessment of marketing authorisation applications and post-authorisation procedures such as variations and renewals. She has contributed to pre- and post-authorisation inspections of pharmaceutical manufacturers, and has supported pharmaceutical manufacturers in developing and maintaining quality systems.

At the European Medicines Agency, Meri has gained experience with the management and regulation of centralised marketing authorisation together with Scientific Committees.

Meri has also worked in the area of drug safety and pharmacovigilance in the pharmaceutical industry and at the European Medicines Agency. She has experience in the collection, management and submission of reports of suspected adverse reactions to medicinal products, conducting local literature searches, and drafting and maintaining SmPCs.

Meri holds a Master’s degree in Pharmacy.

Medimo Pharmacovigilance experts.

Medimo offers everything needed both to get new drugs onto the market and to manage the life cycle of old drugs. It does not matter where you work – contact us!