Soile ja Anu - Medimo.

Medimo Oy

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.

Ulla Nieminen

Ulla Nieminen (PhD) has more than 10 years of experience in the pharmaceutical industry. Ulla specializes in pharmacovigilance processes. She has worked as a qualified person responsible for pharmacovigilance, prepared and maintained pharmacovigilance system master files, led pharmacovigilance database implementation and update projects, and acted as a subject matter expert in these projects. Ulla has EudraVigilance and XEVMPD certificates.

She has also been involved in leading production and R&D projects, for example in different stages of product development and production of sterile eye drops. Ulla has been working in teams that have developed pharmaceutical industry processes and updated the standard operating procedures. Ulla’s strengths are listening to the customer’s needs, detecting flaws in processes, and developing different alternative operating models. In Ulla’s opinion, preparing for pharmacovigilance audits and inspections and the tension brought by their coordination are the best things in pharmacovigilance.

Aura Aalto

Aura has worked in pharmacovigilance for over five years. She is a pharmacist and biochemist by training. Aura started her career in pharmacovigilance in global pharmacovigilance department in the pharmaceutical industry and has since worked via consulting company in different client companies.

Aura’s area of expertise is post-marketing pharmacovigilance. She has strong experience in operative pharmacovigilance tasks, such as adverse reaction reporting and literature searches. Aura has EudraVigilance certificate. She has also worked with pharmacovigilance in Early Access programs. Aura has acted as the EU QPPV for customer companies and has been responsible for maintenance of PSMF.

Aura’s approach to work is customer-oriented and solution-oriented. In addition to improving patient safety, Aura is motivated by the opportunity to develop and learn new things continuously.

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 tasks in 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 pharmacovigilance and quality. Hanna holds a bachelor’s degree in pharmacy and a master’s degree in statistics.

Hanna has strong experience in preparing marketing authorization applications, maintaining marketing authorizations, preparing, updating, and proofreading product information texts, as well as updating SOPs and drafting work instructions. Hanna has handled product complaints, received adverse reaction reports, participated in deviation and CAPA processes, inspections, and audits, and has been involved in drafting change controls and risk assessments.

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!