Category: News

News | 16.08.2022

Our growth story continues – DRA Consulting to become part of the PharmaLex Group

DRA and PharmaLex are merging to create a centre of pharma and Health Tech expertise with nearly 3,000 experts. The merger will bring synergies for the customers of both companies while helping to accelerate Nordic cooperation in the pharmaceuticalmarket.

News | 15.08.2022

Press Release: PharmaLex expands Nordic footprint across key business units with DRA Consulting merger

PharmaLex expands Nordic footprint across key business units with DRA Consulting merger

News | 02.06.2022

A sneak peek to the future: ÄLY seminar puts the spotlight on finnish innovations and solutions for sustainable drug development

In this year’s ÄLY seminar organised by DRA, the discussion turned around different future visions about green pharmacy, corporate social responsibility, the latest innovations in health technology and the possibilities that quantum technology can offer for drug development.

News | 01.06.2022

DADI webinar: What will happen at go-live

The first web-based form to be released in the DADI project is a variations form for human medicinal products, and it is still expected to go live in October 2022.

News | 31.05.2022

Three new guidance documents related to IVD medical devices available

Three guidance documents regarding in vitro diagnostic medical devices were published in May by the Medical Devices Coordination Group (MDCG).

News | 30.05.2022

New experts to join DRA – call for more talents still ongoing

DRA keeps growing! Warmly welcome Virve and Maura.

News | 26.05.2022

Is it a drug or a device? A useful guidance document on borderline products available

The Medical Device Coordination Group (MDCG) has provided guidance on how to better identify the borderline between a medical device and a drug.

News | 28.03.2022

The Medical Device Coordination Group (MDCG) has provided guidance on the appropriate surveillance regarding legacy devices

Some devices may still be placed on the EU markets under the Medical Devices Directives as so-called legacy devices.

News | 28.03.2022

New talents to DRA’s diverse expert teams

Welcome to DRA Hanna Ridderheim, Solja Kalha, Elisa Saarnio ja Henna Torvi!

News | 01.02.2022

A new innovation that makes placing medicinal products on the market quicker and saves money

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. 

News | 31.01.2022

It is a pleasure to introduce our new experts

Welcome Moona, Pauliina, Nina and Joona!

News | 31.01.2022

The extension to the transition period of the IVD Regulation (EU) 2017/746 is now official

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

News | 28.01.2022

Application of the Veterinary Medicines Regulation to begin

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.

News | 17.12.2021

Gift to the sustainable future and green pharmacy

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.

News | 12.10.2021

DRA welcomes new professionals

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.

News | 11.10.2021

Swedish SPC approved for less than 50% of human medicinal products

Fimea reminds marketing authorisation and registration holders of the requirement to submit a Swedish Summary of Product characteristics by 9 February 2022.

News | 11.10.2021

The use of EMA’s Organisation Management Services (OMS) data is extended

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.

News | 11.10.2021

The validity of GMP and GDP certificates are extended until the end of 2022.

The European Commission, EMA and the European medicines regulatory network has updated the activities to ensure the availability of medicines during COVID-19 pandemic.

News | 06.10.2021

MDCG has released guidance for classification of medical devices

The document provides practical examples of devices, including applicable rules and classifications.

News | 06.10.2021

The device and certification module of EUDAMED is now open for registration and searches!

The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.

News | 07.09.2021

DRA’s organisation is developing – Jussi Rysä has been appointed Unit Head

His responsibilities in DRA’s operations are Market Access, Marketing Compliance and Medical Services, Pharmacovigilance and Language and Communications Services.

News | 03.09.2021

DRA joins effort to establish the world’s first professorship in sustainable development in pharmacy in Finland

We want to promote actions that can effectively reduce environmental impact of pharmaceutical manufacturing and the different stages of medicinal product’s life cycle.

News | 25.08.2021

MDCG has released guidance for performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVD) 

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. 

News | 25.08.2021

The Finnish Medicines Agency FIMEA has issued a new administrative regulation on economical operator and device registrations for medical devices 

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. 

News | 29.06.2021

Guidance published by EU-commission on obligations and related rules for the registration in EUDAMED

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.

News | 29.06.2021

SWIXIT – Effects on the current status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices markets

These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.

News | 29.06.2021

Experienced experts and fresh top performers join our DRA team

News | 02.06.2021

Our Health Technology expertise is increasing further

Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.

News | 02.06.2021

Electronic product information – where are we at?

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.

News | 25.05.2021

Zero day MRP/RUP in Iceland

IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).

News | 18.05.2021

Cycling Day 2021 – doing good for the benefit of young people’s mental health

The charitable exercise day will take place on 19 May.

News | 10.05.2021

CMDh: Dexamethasone for the treatment of COVID-19

CMDh has published a summary RMP for medicinal products containing dexamethasone for the treatment of COVID-19.

News | 03.05.2021

Download a guide on the certification and licencing of Life Science products

The guide describe the essential regulatory requirements in Finland and in the EU.

News | 12.04.2021

It is a pleasure to introduce our new experts

Welcome Malena, Adele, Carita, Santtu-Matti, Jussi, Katri and Miika!

News | 07.04.2021

The Swedish Medicines Agency (MPA) is proposing increases in fees

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.

News | 07.04.2021

Guideline on Nordic Packages and Q&A document updated

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.

News | 01.04.2021

EU Digital Application Dataset Integration (DADI) – new eAF formats

A new IT project called the Digital Application Dataset Integration (DADI) has been launched in the EU.

News | 17.03.2021

EMA Medical terms simplifier

EMA has published Medical terms simplifier – a list of plain-language descriptions of medical terms commonly used in information about medicines.

News | 15.02.2021

Monitoring the adverse reactions of COVID-19 vaccines

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.

News | 10.02.2021

Great talents joining DRA

Get to know the experts of our growing team. Welcome to Outi, Jaana, Katariina ja Soile.

News | 15.01.2021

International cooperation in evaluating COVID-19 vaccines and drug therapies

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.

News | 15.01.2021

First notified body approved in Finland

Fimea has approved the first notified body under the new Medical Devices Regulation (MDR), SGS Fimko Oy, in Finland.

News | 21.12.2020

Our team of great colleagues has grown again

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.

News | 26.11.2020

Pharmacovigilance now and in the future – Current topics of the World Drug Safety Congress Europe

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.

News | 16.11.2020

DRA takes part in the ISPOR Europe 2020 

News | 05.10.2020

Growing business requires new kinds of experts

Outi Järvinen, has started work as Head of Resourcing and Accounts in DRA’s sales and marketing team.

News | 19.09.2020

DRA welcomes new professionals

Get to know the experts of our growing team. Welcome to Pia, Virpi, Heli, Stina, Vilhelmiina, Riina and all three Heidi.

News | 17.09.2020

Combining exercise, fun, and charity – Cycling Day on September 17th

This year we’ve support Finnish cancer research in co-operation with the Cancer Foundation Finland.

News | 02.09.2020

DRA takes part in the Nordic Regulatory Affairs seminar

The virtual event gathers Nordic authorities and actors within the pharmaceutical industry together to discuss current topics in their field.

News | 12.08.2020

Expert’s Voice – How to obtain over-the-counter status for a medicinal product Q&A

In this interview, our experienced marketing authorisation expert, will tell about the process and the questions that arise around it at application stage. 

News | 30.06.2020

Recruiting a MARKET ACCESS TEAM LEADER

We are looking for a MARKET ACCESS TEAM LEADER with a solid experience in strategic and operational market access in the Nordic countries.

News | 17.06.2020

It is a pleasure to introduce our new experts 

Over ten new experts have joined us.  Among them, both experienced top experts and new talents. 

News | 28.05.2020

DRA Consulting donates to University of Helsinki coronavirus research

By donating to research, we want to help solve this acute crisis and support our society to recover.

News | 07.04.2020

Our experts and team will help even in a state of emergency

We also want to help secure the operations of our customers.

News | 28.03.2020

Many new experts join DRA – our international expertise is increasing further

Welcome to join us Sari, Jonna, Stina and Jussi!

News | 17.03.2020

Information on the effects of Covid-19 on DRA’s business

Our team of experts is highly committed to support you during this difficult time as well as possible.

News | 01.03.2020

Patients have a voice – Five highlights from the Eupati Nordic Workshop

In future, patient involvement and the patients’ “voice” will have an increasingly important role.

News | 04.02.2020

Great results from our client satisfaction survey

We were particularly thanked for service-mindedness and meeting the agreed timelines as well as for co-operation fostering our clients’ business goals.

News | 10.01.2020

Returnee strengthens the DRA team

DRA has also been joined by a “returnee”, Eija Kinos.

News | 16.12.2019

DRA Consulting Oy wants to help fight the climate change

This year we made a donation to the Finnish Association for Nature Conservation in their climate protection work.

News | 12.11.2019

ISPOR Europe: More transborder co-operation between the authorities is needed in medicines evaluation and health technology assessment

Co-operation can produce high-quality and topical scientific reports, transparent processes and clear requirements for the evidence required.

News | 25.10.2019

Meet us at #ISPOREurope

Join us in Copenhagen on 2-6 November 2019! Drop by booth #C2-011 and have a chat with us.

News | 17.10.2019

TOPRA 2019: Technology poses challenges to the regulatory world – patient involvement is pursued

Is Europe prepared to assess medicines based on new technologies or novel innovations, or different types of study data?

News | 20.09.2019

TOPRA is approaching – See you there!

Meet us at the TOPRA Annual Symposium on 30 September – 2 October 2019 in Dublin, Ireland.

News | 15.08.2019

New EMA guidance on management of medicine shortages

EMA has published guidance to marketing authorisation holders and authorities to improve and harmonise management of medicine shortages and related reporting and communication.

News | 30.05.2019

Information about shortages does not reach prescribers – call for developers of communication voiced at the DRA expert event

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.

News | 08.05.2019

Pauliina Lajunen appointed as Chief Operative Officer of DRA Consulting: “Towards new challenges via a genetic test”

Pauliina Lajunen will help boost DRA’s growth and internationalization with her business and marketing expertise. Welcome Pauliina!

News | 13.04.2019

Risk management materials and clinical work – do they meet?

Availability of risk management materials and electronic systems were much-discussed topics at the traditional pharmacovigilance seminar in Oslo.

News | 29.03.2019

Our team of great colleagues has grown again

Welcome, Suvi, Riina, Niko and Roosa!

News | 06.03.2019

More solid expertise to DRA

Our big team has grown even bigger! Welcome three new colleagues, Heidi, Heli and Tuomas!

News | 02.01.2019

Medicines verification is getting closer – checklist for pharma companies

Medicines verification to deter falsified medicines will be implemented as of 9 February 2019. Are you ready?