A client started getting prepared for the authority inspection. Soon they realised that they lacked both expertise and resources in building up a new GMP qualified manufacturing site for drug substances.
Some devices may still be placed on the EU markets under the Medical Devices Directives as so-called legacy devices.
Welcome to DRA Hanna Ridderheim, Solja Kalha, Elisa Saarnio ja Henna Torvi!
Heli Tenhola, M.Sc. (Pharmacy), has worked at DRA for soon 10 years. Heli started her career at DRA already during her studies, and thanks to the experience she has gained through the years, she has been trusted with more versatile and more responsible expert roles in the pharmaceutical industry.
Doctor of Pharmacy Anne Soikkeli joined DRA about 6 years ago as she shifted from a pharma company to DRA Consulting in aim to learn new things and to get a wider perspective to the pharmaceutical industry.
During the past 15 years, M.Sc. (Pharmacy) Henriikka Larjomaa has seen DRA Consulting to grow from a few dozens of employees to over a hundred, and she herself has also been involved in a great variety of tasks.
What is your role, and what are your duties at DRA now? Right now, I’m in a transition period: I’m about to start as the team leader of our Market Access team. I work on pharmaceutical pricing and reimbursement matters, and in addition, I have duties related to placing new medicines on the market. I’m […]
Press Release: A Finnish company is digitalising the process of writing marketing authorisation applications – the sections describing the medicinal product’s manufacturing and quality can be completed in half the time with the new DRA Variator® software.
Welcome Moona, Pauliina, Nina and Joona!
On 28th of January 2022, the European Commission published in the Official Journal of the European Union an amending regulation as regarding to the transitional provisions of the in vitro diagnostic medical device (IVD) regulation for certain IVD medi
The Veterinary Medicines Regulation (2019/6) will be applied as-is in all EU Member States from 28 January 2022. The Regulation will lead to changes in the pharmacovigilance, distribution and marketing of veterinary medicinal products, as well as applying for marketing authorisation and maintaining it.
M. Sc. (Pharmacy) Saima Joutsiniemi has worked at DRA Consulting for soon 15 years. Before joining DRA, she had gained experience in pharmaceutical wholesale and quality assurance expert’s tasks.
M. Sc. (Pharmacy) Tuomas Tepponen joined DRA in January 2019, and like many of DRA’s experts, he works as a consultant inside one of our client companies.
We made a donation to the sustainable pharmacy fund of the University of Helsinki and the new professorship. With this donation, we want to support the establishment of the world’s first professorship in sustainable development in pharmacy.
DRA continues to grow and we are proud to introduce our new team of experts. Welcome Henna Juvonen, Elsi Tuominen, Militsa Kukko, Roosa Bäck, Pia Mustakangas, Jasmin Pyrhönen ja Vilhelmiina Peltoniemi.
Fimea reminds marketing authorisation and registration holders of the requirement to submit a Swedish Summary of Product characteristics by 9 February 2022.
The latest application form version has been published on 1 October 2021 and the use of the form and OMS information is mandatory from 1 November 2021.
The European Commission, EMA and the European medicines regulatory network has updated the activities to ensure the availability of medicines during COVID-19 pandemic.
The document provides practical examples of devices, including applicable rules and classifications.
The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.
You need to be familiar with the Finnish reference price system in order to submit price notifications appropriately and on schedule. At worst, forgetting to submit price notification may lead to the medicinal product losing its reimbursability.
The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.
The idea of the challenge is to clock up 1,000 kilometres in a year without any help from motors. Many DRA employees took up the challenge, and we were also able to involve our customers.
His responsibilities in DRA’s operations are Market Access, Marketing Compliance and Medical Services, Pharmacovigilance and Language and Communications Services.
We want to promote actions that can effectively reduce environmental impact of pharmaceutical manufacturing and the different stages of medicinal product’s life cycle.
A new Finnish national legislation has entered into force.
The content of released guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months.
The new regulation implements the obligations set out in medical device EU-regulations (2017/745 and 2017/746) and in national legislation 719/2021 in Finland.
Experiences in successful adaptation of B2B service selling during these exceptional times.
Medicinal products and medical devices alike can be used to diagnose, prevent, treat, and alleviate diseases, or to correct, restore or modify physiological processes.
To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.
These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.
During this spring, many experienced experts and fresh top performers have joined our team. The team of Marketing supervision and Medical services has been complemented with two new top experts. Kati Mönkkönen, Ph.D., has years of experience in the pharmaceutical industry, e.g. from Sanquin and Biogen. Her experience especially covers medical assignments. Anna Hiltunen, who […]
When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes.
Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.
Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.
When it comes to electronic product information, a central question is the patient’s digital health information literacy. At the moment, there is electronic product information available, but the challenge is how accessible and easy-to-find it is.
Determining which legislation a product falls under is essential. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.
IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).
One of the most significant new regulatory provisions is related to the increased requirements for internal monitoring by companies, namely the designation of a Person Responsible for Regulatory Compliance (PRRC).
The charitable exercise day will take place on 19 May.
If your company works in the field of medical devices, it is important for you to know that the new Medical Devices Regulation (MDR, EU 2017/745) requires all manufacturers of medical devices to have a quality management system.
CMDh has published a summary RMP for medicinal products containing dexamethasone for the treatment of COVID-19.
The guide describe the essential regulatory requirements in Finland and in the EU.
Welcome Malena, Adele, Carita, Santtu-Matti, Jussi, Katri and Miika!
On March 2, 2021, the MPA has proposed to the Swedish government an increase in fees for control of medicinal products as of January 1, 2022. The reason for the increases is mentioned e.g. increase in operating costs.
The Nordic Co-operation Group has updated the Guideline on common Nordic packaging materials and the Q&A document. Four new questions have been added to the Q&A document. Some of the existing questions/answers have also been updated.
A new IT project called the Digital Application Dataset Integration (DADI) has been launched in the EU.
Adverse reactions are carefully monitored in clinical trials before a drug enters the market, and after that they remain under constant monitoring throughout the life cycle of the drug. Every report on adverse drug reactions is important for the evaluation of the safety and efficacy of a drug.
EMA has published Medical terms simplifier – a list of plain-language descriptions of medical terms commonly used in information about medicines.
new pharmaceutical production is not set up by clicking fingers. The process is slow and multi-stage, and everything is done in the name of patient safety.
On January 27, 2021, Fimea opened a website for adverse reaction reports for coronavirus vaccines. The page is updated more than once a week by the number and severity of adverse reaction reports.
Get to know the experts of our growing team. Welcome to Outi, Jaana, Katariina ja Soile.
EMA has launched a new OPEN pilot to increase international cooperation in evaluating COVID-19 vaccines and drug therapies. The project started in December 2020.
Fimea has approved the first notified body under the new Medical Devices Regulation (MDR), SGS Fimko Oy, in Finland.
Pharmacist specialising in industrial pharmacy Linda Tossavainen-Nikki, MBA and B.Sc. (Pharm.), and pharmacist Anna-Kaisa Tuderman, M.Sc. (Pharm), are joining our regulatory services team. Sami Tyrjy B.Sc. (Pharm.) has started as a new employee in our sales and marketing team.
Read our expert blog how was it possible to develop a safe and effective vaccine within this timeline.
Future trends were emphasised strongly in the discussion, especially with regard to the development possibilities introduced by new technological solutions. Read the highlights of the event.
DRA’s Market Access experts participate in the virtual ISPOR Europe 2020 conference. The theme of the four-day event is Improving Health: Establishing Incentives and Sharing Value. The aim of the event is to find new perspectives with the global network of HEOR experts on how we establish and share value sustainable for health systems, patients, and technology developers. Virtual ISPOR Europe 2020 will […]
Outi Järvinen, has started work as Head of Resourcing and Accounts in DRA’s sales and marketing team.
Mergers of pharmaceutical companies always involve big changes and difficult decisions. What should be done with the role of the responsible person when there will only be one position left after the merger? Read about our thoughts on the topic on our blog.
Get to know the experts of our growing team. Welcome to Pia, Virpi, Heli, Stina, Vilhelmiina, Riina and all three Heidi.
This year we’ve support Finnish cancer research in co-operation with the Cancer Foundation Finland.
The virtual event gathers Nordic authorities and actors within the pharmaceutical industry together to discuss current topics in their field.
In this interview, our experienced marketing authorisation expert, will tell about the process and the questions that arise around it at application stage.
We are looking for a MARKET ACCESS TEAM LEADER with a solid experience in strategic and operational market access in the Nordic countries.
Over ten new experts have joined us. Among them, both experienced top experts and new talents.
By donating to research, we want to help solve this acute crisis and support our society to recover.
How are we ensuring availability in Finland today, and what more could we do? See our blog for a list of measures in place.
We also want to help secure the operations of our customers.
Emergency conditions or not, we move forward with our daily lives. Amidst the meetings, processing, and consultation, we always make time for a quick online coffee meet-up.
Welcome to join us Sari, Jonna, Stina and Jussi!
Our team of experts is highly committed to support you during this difficult time as well as possible.
In future, patient involvement and the patients’ “voice” will have an increasingly important role.
We were particularly thanked for service-mindedness and meeting the agreed timelines as well as for co-operation fostering our clients’ business goals.
DRA has also been joined by a “returnee”, Eija Kinos.
This year we made a donation to the Finnish Association for Nature Conservation in their climate protection work.
Co-operation can produce high-quality and topical scientific reports, transparent processes and clear requirements for the evidence required.
Customers often head for a pharmacy also in matters not involving prescription medicines, and the selection of OTC medicines seems dizzying even to a pharmaceutical professional.
Join us in Copenhagen on 2-6 November 2019! Drop by booth #C2-011 and have a chat with us.
Is Europe prepared to assess medicines based on new technologies or novel innovations, or different types of study data?
Meet us at the TOPRA Annual Symposium on 30 September – 2 October 2019 in Dublin, Ireland.
EMA has published guidance to marketing authorisation holders and authorities to improve and harmonise management of medicine shortages and related reporting and communication.
Issues related to availability of medicines have been in the headlines in all over Europe.
The expert event brought together more than 50 representatives of the pharma industry and medicinal wholesalers to exchange experiences and thoughts on how to control availability of medicines.
Pauliina Lajunen will help boost DRA’s growth and internationalization with her business and marketing expertise. Welcome Pauliina!
In future, the package leaflet may be an electronic smart document which reminds you to take your pill or to renew a prescription.
Availability of risk management materials and electronic systems were much-discussed topics at the traditional pharmacovigilance seminar in Oslo.
Welcome, Suvi, Riina, Niko and Roosa!
Our big team has grown even bigger! Welcome three new colleagues, Heidi, Heli and Tuomas!
Medicines verification to deter falsified medicines will be implemented as of 9 February 2019. Are you ready?
Many pharmaceutical companies have not yet submitted the necessary applications, and the deadline is already around the corner.
From the perspective of a person working in the pharmaceutical industry, the benefit/risk relationship of clear language is solely positive as benefits are numerous yet there are no adverse effects at all.
Multilingual Nordic packages are an important option for making medicines available in as many countries in the Nordic region as possible.
Last autumn, DRA was invited to participate in a pilot project concerned with real-life testing of the Pharmaceuticals Pricing Board’s electronic services.