A pilot into the jungle consort group of rules and guidelines on innovations
Home News Research and Development Knowledge Management Unequal Care Patient Safety Collaboration consort group in Health Care Care Results Opinion Research Knowledge consort group Management Unequal Care Patient Care Collaboration Results About LIF About Life time.se Copyright Subscribe Newsletter Archives Filmkontakt
Are you working on the development of pharmaceuticals and medical devices and think that the rules are convoluted and hard to find? Now there Innovation Office at the MPA showing the way for researchers and small and medium consort group enterprises. consort group Innovation Office would also like to highlight the scientific advice given by the MPA.
The pharmaceutical world is in constant consort group change. There is an extensive restructuring of the global pharmaceutical companies. consort group While some pharmaceutical companies are forced to close down units, start new innovative businesses.
Last autumn, the government also his research bill "Research and innovation" which proposes an increase in research with four billion during the years 2013 to 2016 Should Sweden keep up with developments and be one of the world's leading research nations also need conditions for innovation to be good .
- We want to be with and support innovation in the life science sector. By that we mean the development of drugs and medical devices, says Susanne Baltzer, head of the newly established Innovation Office at the MPA. Innovation requires collaboration
She is basically a PhD biochemist who has worked for many years in the pharmaceutical consort group industry. She has also been responsible for the building of protein chemical laboratory at the company consort group Medivir AB, Huddinge.
- I have spent many years working with drug development. For the MPA, I came three years ago as a group manager consort group for pharmaceutical investigators who examine applications for biologics. Since the first of January this year, I am responsible for Innovation Office, says Susanne Baltzer. Challenges of several different kinds
The trend shows that the need for new drugs and medical devices is increasing. We get an older population. In pace with the technological development increases the chances for a more individualized care and treatment. New markets emerge also as the developing countries get a better economy.
- The challenges for pharmaceutical companies is that the cost per approved drug that reaches the market is increasing. This means increased price pressure, which places greater demands on multidisciplinary collaboration within and between enterprises. The landscape is being redrawn, innovation requires a greater degree than previous collusion. Here we have an important role, says Susanne Baltzer. Regulatory and Scientific Advice
Innovation Office, which began operations at the end of the year, would make it easier and clearer to find a way into the MPA, but also increase knowledge consort group and awareness about the agency's services that are linked to particular innovation.
- We want to be an important pilot and advisor for companies and innovators in regulatory and scientific issues. Despite the fact that every year we receive about 200 companies and research groups for advice, awareness and knowledge of the MPA's operations limited. This is particularly true among small and medium-sized businesses, says Susanne Baltzer. Most via phone and email
Regulatory advice is usually done via email or by phone and can be about issues related regulations regarding clinical trials and approval of new drugs. The regulatory advice is free and can be done separately or in conjunction consort group with scientific advice.
When scientific advice, which is chargeable, you get the opportunity to book an appointment and meet with the MPA experts. A few weeks before the meeting to send in their evidence and their questions. There are questions surrounding consort group the manufacture of a medicament or questions about preclinical or clinical documentation. consort group
- Maybe you want to get further information about what data is required to meet the requirements of a safe and effective product. It can also involve planning for a clinical study, and a discussion of which patients should be included, says Susanne Baltzer. Sounding board and support the development
However, it is important to stress, she says, the Innovation Office does not assist in the effort to write applications or to produce data and documentation. consort group Innovation Office will also no pre-valuation of the documentation with respect to a drug's marketing consort group authorization.
- It is not our role to take over the responsibility of companies to develop their products. consort group We do not reimburse consultants who help companies, for example, writing applications and provide relevant input. But we can be a sounding board. It's fine to get many times and we are trying to help in the best way, says Susanne Baltzer.
MPA has also information about regulat
Home News Research and Development Knowledge Management Unequal Care Patient Safety Collaboration consort group in Health Care Care Results Opinion Research Knowledge consort group Management Unequal Care Patient Care Collaboration Results About LIF About Life time.se Copyright Subscribe Newsletter Archives Filmkontakt
Are you working on the development of pharmaceuticals and medical devices and think that the rules are convoluted and hard to find? Now there Innovation Office at the MPA showing the way for researchers and small and medium consort group enterprises. consort group Innovation Office would also like to highlight the scientific advice given by the MPA.
The pharmaceutical world is in constant consort group change. There is an extensive restructuring of the global pharmaceutical companies. consort group While some pharmaceutical companies are forced to close down units, start new innovative businesses.
Last autumn, the government also his research bill "Research and innovation" which proposes an increase in research with four billion during the years 2013 to 2016 Should Sweden keep up with developments and be one of the world's leading research nations also need conditions for innovation to be good .
- We want to be with and support innovation in the life science sector. By that we mean the development of drugs and medical devices, says Susanne Baltzer, head of the newly established Innovation Office at the MPA. Innovation requires collaboration
She is basically a PhD biochemist who has worked for many years in the pharmaceutical consort group industry. She has also been responsible for the building of protein chemical laboratory at the company consort group Medivir AB, Huddinge.
- I have spent many years working with drug development. For the MPA, I came three years ago as a group manager consort group for pharmaceutical investigators who examine applications for biologics. Since the first of January this year, I am responsible for Innovation Office, says Susanne Baltzer. Challenges of several different kinds
The trend shows that the need for new drugs and medical devices is increasing. We get an older population. In pace with the technological development increases the chances for a more individualized care and treatment. New markets emerge also as the developing countries get a better economy.
- The challenges for pharmaceutical companies is that the cost per approved drug that reaches the market is increasing. This means increased price pressure, which places greater demands on multidisciplinary collaboration within and between enterprises. The landscape is being redrawn, innovation requires a greater degree than previous collusion. Here we have an important role, says Susanne Baltzer. Regulatory and Scientific Advice
Innovation Office, which began operations at the end of the year, would make it easier and clearer to find a way into the MPA, but also increase knowledge consort group and awareness about the agency's services that are linked to particular innovation.
- We want to be an important pilot and advisor for companies and innovators in regulatory and scientific issues. Despite the fact that every year we receive about 200 companies and research groups for advice, awareness and knowledge of the MPA's operations limited. This is particularly true among small and medium-sized businesses, says Susanne Baltzer. Most via phone and email
Regulatory advice is usually done via email or by phone and can be about issues related regulations regarding clinical trials and approval of new drugs. The regulatory advice is free and can be done separately or in conjunction consort group with scientific advice.
When scientific advice, which is chargeable, you get the opportunity to book an appointment and meet with the MPA experts. A few weeks before the meeting to send in their evidence and their questions. There are questions surrounding consort group the manufacture of a medicament or questions about preclinical or clinical documentation. consort group
- Maybe you want to get further information about what data is required to meet the requirements of a safe and effective product. It can also involve planning for a clinical study, and a discussion of which patients should be included, says Susanne Baltzer. Sounding board and support the development
However, it is important to stress, she says, the Innovation Office does not assist in the effort to write applications or to produce data and documentation. consort group Innovation Office will also no pre-valuation of the documentation with respect to a drug's marketing consort group authorization.
- It is not our role to take over the responsibility of companies to develop their products. consort group We do not reimburse consultants who help companies, for example, writing applications and provide relevant input. But we can be a sounding board. It's fine to get many times and we are trying to help in the best way, says Susanne Baltzer.
MPA has also information about regulat
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