Category: Blogs

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Blogs |

There is strength in numbers – DRA crowdsources visioning of the future

Last year, we engaged all of our 100-plus employees in the organisation’s strategy work and visioning the future. This way, we managed to harness the silent knowledge of all our employees for the company’s foresight process, and by crowdsourcing, we also future-proofed our strategy.

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Blogs |

One month till the new dawn – EU IVDR will be applied in full in May 2022

In this blog post, our Health Tech Team Leader Tiina Riihimäki provides an overview of the latest developments and the foreseeable challenges in the process. Read her expert advice on how to prepare for this historic legislative change.

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Blogs |

DRA Driving Responsible Action

What does responsibility mean to you? What would you set as your goal for social responsibility in 2022? These are some of the questions that all DRA’s employees were asked in the beginning of this year.

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Blogs |

Five tips for the reference price jungle

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.

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Blogs |

Assessing the biological safety is a measure that protects both the user and manufacturer of a medical device.

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.

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Blogs |

The Camino de Hope campaign challenges DRA employees to start exercising

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.

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Blogs |

MD/IVD Regulation causes changes to national legislation in EU member states

 A new Finnish national legislation has entered into force.

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Blogs |

Sales is undergoing major changes: from personal selling to hybrid selling led by COVID-19

Experiences in successful adaptation of B2B service selling during these exceptional times.

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Blogs |

Mode of action defines whether your product is a medicinal product or a medical device

Medicinal products and medical devices alike can be used to diagnose, prevent, treat, and alleviate diseases, or to correct, restore or modify physiological processes.

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Blogs |

Do you know which designation codes are applicable to medical devices manufactured by your company?

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.

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Blogs |

Notified Body – A business-critical relationship

Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.

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Blogs |

Is your product a medicinal product, a medical device, or both?

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.

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Blogs |

What is a PRRC and why is it necessary to have one when the new MD Regulation enters into force?

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).

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Blogs |

The MD Regulation is entering into force – is your quality management system in order?

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.

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Blogs |

Reporting of adverse drug reactions protects users of pharmaceutical products

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.

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Blogs |

Pharmaceutical production is not set up overnight

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.

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Blogs |

COVID-19 vaccine: 10 years of work in 10 months, how was this possible?

Read our expert blog how was it possible to develop a safe and effective vaccine within this timeline.

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Blogs |

When two become one: The merger of pharmaceutical companies always creates turmoil behind the scenes

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.

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Blogs |

Ensuring availability of medicines amidst the coronavirus crisis requires flexibility

How are we ensuring availability in Finland today, and what more could we do? See our blog for a list of measures in place.

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Blogs |

A typical day in the life of a consultant (even in emergency conditions)

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.

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Blogs |

When the patient is in charge – thoughts at a pharmacy’s OTC shelves

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.

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Blogs |

Why pharmacies run short of medicines – should we be worried?

Issues related to availability of medicines have been in the headlines in all over Europe.

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Blogs |

What if you could read a package leaflet without a magnifying glass – and the leaflet also gave you advice?

In future, the package leaflet may be an electronic smart document which reminds you to take your pill or to renew a prescription.

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Blogs |

Brexit is coming – is your product portfolio ready?

Many pharmaceutical companies have not yet submitted the necessary applications, and the deadline is already around the corner.

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Blogs |

Clear language saves time and money – also in the pharmaceutical industry

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.

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Blogs |

Multilingual Nordic packages against availability problems

Multilingual Nordic packages are an important option for making medicines available in as many countries in the Nordic region as possible.

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Blogs |

A new digital era is dawning for PBB services

Last autumn, DRA was invited to participate in a pilot project concerned with real-life testing of the Pharmaceuticals Pricing Board’s electronic services.

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