Danish Medicines Agency

Copenhagen, Denmark

Danish Medicines Agency

Copenhagen, Denmark

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TORONTO--(BUSINESS WIRE)--Bio Pharma Services, Inc. (Bio Pharma) ended their 10th year anniversary celebrations by announcing the successful EMA inspection of their Toronto based clinical and bioanalytical site. The 5-day inspection which included a complete audit of their clinical, bioanalytical and pharmacokinetic units, was the first inspection conducted by the French National Agency for Medicines and Health Products Safety (ANSM) and the Danish Medicines Agency (DKMA) at Bio Pharma. With the strong and positive outcome of this last inspection, Bio Pharma continues to build on its impressive regulatory achievements, having now completed inspections for all major jurisdictions in the global marketplace. Bio Pharma's outstanding regulatory history includes successful inspections by the US FDA, UK MHRA, Health Canada, Standards Council of Canada and ANVISA. “This EU GCP audit comes on the heels of Bio Pharma successfully renewing its GLP certification with the Standards Council of Canada (SCC) just last week. Our attention to detail and high quality is what sets us apart in the marketplace. I am very proud of our contributions to safe and effective medicines,” stated Bio Pharma’s CEO, Renzo DiCarlo. Andjica Tasic, Vice-President, Quality Assurance and Regulatory Affairs at Bio Pharma added: "The successful outcome of this EMA inspection was years in the making. All of us here at Bio Pharma are committed to continuous improvement in our pursuit of excellence and executing R&D to the highest of standards.” Bio Pharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide. With clinical facilities in Columbia, Missouri and Toronto, Canada, Bio Pharma’s total bed capacity sits at 250 with an impressive subject database of healthy volunteers, special populations (which includes post-menopausal females, hypogonadal males, and recreational drug users) and patients. Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.


Pharma Cold Chain Distribution: Big Pharma, MHRA and Leading Logistics Companies to Meet in London This December at SMi's Cold Chain Distribution SMi Group reports: World Courier, Finnair, MHRA, IATA, Teva, GSK, J&J, Sanofi will meet in London this December at Cold Chain Distribution 2016. London, United Kingdom, November 30, 2016 --( Just a fortnight remains until the SMi Group opens their doors to host the 11th annual conference on Cold Chain Distribution. This year’s event will bring over 120 attendees from all over the world including senior representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments. Further information available at www.coldchain-distribution.com/PrCom. Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more. The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PrCom. "The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair Confirmed attendees include key decision makers from Accord Healthcare, Actelion Pharmaceuticals UK, Al Medicines, Alliance Healthcare, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Brussels Airport Company, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Eli Lilly Italia SpA, Envirotainer, Exelsius, Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Novartis Business Services, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more. “We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” - David Spillett, Key Account Director, World Courier Further information available at www.coldchain-distribution.com/PrCom. Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier. Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, NEFTAG, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport. 11th Annual Cold Chain Distribution Conference and Exhibition Park Plaza Victoria, London, UK 12th-13th December, 2016 www.coldchain-distribution.com/PrCom Sponsors/Exhibitors: Contact Alia Malick on amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum on fbegum@smi-online.co.uk Media Enquiries: Contact Julia Rotar on jrotar@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk. London, United Kingdom, November 30, 2016 --( PR.com )-- Over the last 24 months, the new logistics hubs have been established around the globe by forwarders and distributors, in order to service and support a more round-the-clock global network for pharmaceutical product supply. Nonetheless, challenges remain with the increasingly fragile biologics product and tightened GDP regulations.Just a fortnight remains until the SMi Group opens their doors to host the 11th annual conference on Cold Chain Distribution. This year’s event will bring over 120 attendees from all over the world including senior representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments.Further information available at www.coldchain-distribution.com/PrCom.Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more.The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PrCom."The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, FinnairConfirmed attendees include key decision makers from Accord Healthcare, Actelion Pharmaceuticals UK, Al Medicines, Alliance Healthcare, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Brussels Airport Company, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Eli Lilly Italia SpA, Envirotainer, Exelsius, Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Novartis Business Services, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more.“We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” - David Spillett, Key Account Director, World CourierFurther information available at www.coldchain-distribution.com/PrCom.Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier.Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, NEFTAG, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport.11th Annual Cold Chain Distribution Conference and ExhibitionPark Plaza Victoria, London, UK12th-13th December, 2016www.coldchain-distribution.com/PrComSponsors/Exhibitors: Contact Alia Malick on amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum on fbegum@smi-online.co.ukMedia Enquiries: Contact Julia Rotar on jrotar@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk. Click here to view the list of recent Press Releases from SMi Group


SMi Group reports: World Courier, Finnair, MHRA, IATA, Teva, GSK, J&J, Sanofi will meet in London this December at Cold Chain Distribution 2016 London, United Kingdom, November 17, 2016 --( 11th annual Cold Chain Distribution, taking place in London, UK, on the 12th and 13th of December, brings together 100+ representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments! Further information available at www.coldchain-distribution.com/PRCom Cold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more. The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PRCom “The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair. Confirmed attendees include key decision makers from Accord Healthcare, Al Medicines, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Envirotainer, Exelsius , Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more! “We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” -David Spillett, Key Account Director, World Courier. Further information available at www.coldchain-distribution.com/PRCom Cold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier. Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport. 11th Annual Cold Chain Distribution Conference and Exhibition Park Plaza Victoria, London, UK 12th-13th December, 2016 www.coldchain-distribution.com/PRCom Sponsors/Exhibitors: Contact Alia Malick at +44 (0) 7827 6168, amalick@smi-online.co.uk Delegates/Groups: Contact Fateja Begum at +44 (0) 20 7827 6184, fbegum@smi-online.co.uk Media Enquiries: Contact Julia Rotar at jrotar@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, November 17, 2016 --( PR.com )-- Over the last 24 months, new logistics hubs have been established around the globe by forwarders and distributors, in order to service and support a more round-the-clock global network for pharmaceutical product supply. Nonetheless, challenges remain with the increasingly fragile biologics product and tightened GDP regulations.11th annual Cold Chain Distribution, taking place in London, UK, on the 12th and 13th of December, brings together 100+ representatives from big pharma, biotech and service providers with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, QA and QC from Austria, Belgium, Denmark, Finland, France, Ireland, Israel, Netherlands, Switzerland, United Kingdom and other countries to keep abreast of cold chain distribution developments!Further information available at www.coldchain-distribution.com/PRComCold Chain Distribution 2016 speaker line up includes key decision makers and leading pharma cold chain experts representing MHRA, Danish Medicines Agency, IATA, NHS Blood & Transplant, Sanofi-Aventis, Johnson & Johnson, GlaxoSmithKline, GSK Biologicals, Teva Pharmaceutical, The Grimsby Institute, World Courier, Finnair Cargo, PCI Pharma Services, Cell and Gene Therapy Catapult, Modalis, Exelsius, Vertex International Ltd and more.The complete 2-day event programme including all speakers and their topics can be viewed at www.coldchain-distribution.com/PRCom“The aviation industry has made improvements for cold chain distribution, despite improvements there are still challenges that remain unanswered. It's time to discuss the next trends of cold chain distribution as air cargo." - Frederik Wildtgrube, Head of Global Sales, Finnair.Confirmed attendees include key decision makers from Accord Healthcare, Al Medicines, Almac Group, Avery Dennison Materials Europe B.V., BIOTRANS SA, Birmingham Children’s Hospital, Bristol-Myers Squibb, Business Unit Pharma, Catapult Cell & Gene Therapy, Cell Therapy Catapult, Copenhagen Capacity, Copenhagen Univeristy, Danish Medicines Agency, Day Lewis Plc, DBS Ltd, Eberspaecher, Envirotainer, Exelsius , Finnair Cargo, Genzyme Pharmaceuticals, GlaxoSmithKline, GSK Biologicals, GW Pharmaceuticals, IATA, Janssen Pharmaceutica N.V., JB360solutions, Johnson & Johnson, Kings College London, Kyowa Kirin International plc., Lysogene, MHRA, Modalis, MSD, NHS Blood & Transplant, Norgine Ltd, Panalpina, PCI Pharma Services, Pfizer Group, Porton Biopharma, ReNeuron, Roche Pharmaceuticals, Sanofi-Aventis, Seer Pharma, Shionogi Ltd, Shire/Global Logistics Validation, Softbox Systems Ltd, Teva Pharmaceutical, The Doctors Laboratory Ltd, The Grimsby Institute, va-Q-tec AG, Vertex Pharmaceuticals (Europe), Wockhardt UK, World Courier, Yourway Transport and many more!“We consider SMi’s Cold Chain Distribution conference as the industry-leading event in the UK which has always attracted a good mix and level of speakers and delegates, including both our customers and suppliers, who are all key opinion leaders in their respective fields. It serves as a good platform for us to engage with attendees, share best practices and challenge our theories on the future of temperature controlled distribution. As cold chain distribution is our core business, it’s imperative that we continue to evolve in accordance with the needs of our customers.” -David Spillett, Key Account Director, World Courier.Further information available at www.coldchain-distribution.com/PRComCold Chain Distribution 2016 offers to its attendees a fantastic networking opportunity with the leading experts in the industry at a drinks reception on day one followed by a Gala Dinner (invitation only) hosted by World Courier.Cold Chain Distribution 2016 is proud to be sponsored by the leading service providers including: World Courier (Lead Sponsor), Berlinger & Co. AG, Eberspächer, ELPRO, Emball'iso, Finnair Cargo, Peli BioThermal, Sensitech, SMO Group, Testo Limited, Topa Thermal, va-Q-tech and Yourway Transport.11th Annual Cold Chain Distribution Conference and ExhibitionPark Plaza Victoria, London, UK12th-13th December, 2016www.coldchain-distribution.com/PRComSponsors/Exhibitors: Contact Alia Malick at +44 (0) 7827 6168, amalick@smi-online.co.ukDelegates/Groups: Contact Fateja Begum at +44 (0) 20 7827 6184, fbegum@smi-online.co.ukMedia Enquiries: Contact Julia Rotar at jrotar@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


Callreus T.,Danish Medicines Agency
Acta Paediatrica, International Journal of Paediatrics | Year: 2010

Given the serious consequences of low vaccine coverage, concerns and misconceptions need to be taken seriously and responded to appropriately to sustain accomplishments of immunization programmes. For parental decisions related to childhood vaccinations, it seems reasonable to assume that the cultural context of the immunization programme is of importance. This article is a short review of some recent studies of parental decision-making on vaccination in developed countries Kazaktstan, Uzbekistan and Northern Nigeria. Furthermore, an attempt is made to relate the findings in these studies to theoretical models of parental decision-making. Conclusion: For the implementation of immunization programmes, it is important to develop an in-depth understanding of mechanisms underlying decisions to accept or reject the vaccination of a child. Theoretical models may aid in the understanding of these mechanisms. © 2009 Foundation Acta Pædiatrica.


Pasternak B.,Statens Serum Institute | Svanstrom H.,Statens Serum Institute | Callreus T.,Danish Medicines Agency | Melbye M.,Statens Serum Institute | Hviid A.,Statens Serum Institute
Circulation | Year: 2011

Background-: A recent meta-analysis of randomized trials suggested that use of angiotensin receptor blockers (ARBs) may be associated with a modestly increased risk of incident cancer, particularly lung cancer. Methods and Results-: We linked individual-level data from Danish registries on filled drug prescriptions, diagnostic information, and covariates. In a nationwide cohort of new users of ARBs and angiotensin-converting enzyme inhibitors ≥35 years of age during 1998 to 2006, we compared incidence rates of all cancer, cancer subgroups by anatomic site, and cancer mortality. Among 107 466 ARB users, 3954 cases of cancer were detected during 312 753 person-years of follow-up compared with 6214 cases during 435 207 person-years of follow-up in 209 692 angiotensin-converting enzyme inhibitor users (adjusted rate ratio, 0.99; 95% confidence interval, 0.95 to 1.03). Cancer risk did not increase with increasing duration of ARB exposure (increase in rate ratio per year, 0.99; 95% confidence interval, 0.99 to 1.00,) and was similar across individual ARBs. In subgroup analyses, there was a significant association between ARB use and cancer of male genital organs (rate ratio, 1.15; 95% confidence interval, 1.02 to 1.28), but no significantly increased risk of any of the other 15 cancer subgroups, including lung cancer (rate ratio, 0.92; 95% confidence interval, 0.82 to 1.02). For cancer mortality, the rate ratio was 0.77 (95% confidence interval, 0.72 to 0.82). Conclusions-: In this large nationwide cohort, use of ARBs was not significantly associated with increased risk of incident cancer overall or of lung cancer. © 2011 American Heart Association, Inc.


Cox M.A.,Danish Medicines Agency | Kastrup J.,Copenhagen University | Hrubisko M.,Slovak Medical University
Cell and Tissue Banking | Year: 2012

A retrospective review of the published literature identified several hundred adverse reactions (e.g. nausea, chills, cardiac arrhythmias, neurological symptoms and respiratory arrest) associated with the transplantation of stem cells cryopreserved with dimethyl sulfoxide. The occurrences of these are generally accepted as commonplace, as the majority of reactions are transient, whilst a few patients may require clinical treatment. This exploratory study is acollation of the historical data and the expectations for the notification of serious adverse reactions. Outline information is presented on the development of related European Directives, some technical aspects of dimethyl sulfoxide and the sequential stages of preservation and administration. © 2011 Springer Science+Business Media B.V.


Folkenberg M.,Danish Medicines Agency | Callreus T.,Danish Medicines Agency | Svanstrom H.,Statens Serum Institute | Valentiner-Branth P.,Statens Serum Institute | Hviid A.,Statens Serum Institute
Vaccine | Year: 2011

Our study reviews the spontaneous reports of adverse events following immunisation submitted to the Danish Medicines Agency during the 2009-2010 influenza A/H1N1v season. During the study period (4 November 2009-31 March 2010), 607 reports comprising 1885 adverse events were reported among 339,507 influenza A/H1N1v vaccinated individuals (reporting rate, 179 per 100,000 vaccinated). The majority of individual case safety reports (85%) were submitted by physicians and other health care professionals and concerned known and non-serious reactions occurring within 1 day of vaccination (82%). Events of special interest as defined by EMA prior to vaccination campaign start, comprised 1% of all events. In conclusion, we did not observe any strong signals of any unknown or serious adverse events associated with influenza A/H1N1v vaccination in Denmark. Our experience also demonstrates the well-known limitations of spontaneous reports with respect to evaluation of a casual relationship and highlights the importance for a timely availability of background events rates and the need for new approaches to study late adverse effects following immunisation. © 2010 Elsevier Ltd.


Winther L.,Danish Medicines Agency
Veterinary Journal | Year: 2012

The distribution of antimicrobial drugs in the equine lung is important in designing optimal dosage regimens for the treatment of lower airway infections. Several studies in horses and other species have shown that the pharmacokinetics of a drug in the lung cannot necessarily be predicted by its behaviour in plasma, and influencing factors include the class of drug, the animal species and the chosen sampling technique. This review provides a description of the target site for bacterial lower airway infections and describes the penetration of antibiotics into lung matrices. It also offers an overview of published equine pulmonary pharmacokinetic studies and considers the different sampling methods used and the influence existing methodological problems can have on the interpretation of data. An awareness of these factors is important in establishing optimal dosage regimes to treat lower airway infections in horses. © 2012 Elsevier Ltd.


Svanstrm H.,Statens Serum Institute | Callrus T.,Danish Medicines Agency | Hviid A.,Statens Serum Institute
Drug Safety | Year: 2010

Background: A rarely used opportunity in pharmacovigilance is data mining for adverse drug reactions (ADRs) in population-based healthcare databases. Objective: To evaluate the potential of data mining for ADRs in the nationwide Danish healthcare databases. We specifically considered hospital contacts following measles, mumps and rubella (MMR) immunization. Methods: We constructed a cohort consisting of all children born in Denmark from 1995 to 2007 (n = 918 831) with individual-level linked data on childhood vaccinations and hospital contacts from the nationwide Danish healthcare databases. We applied a cohort-based data mining methodology to compare the observed versus the expected incidence of adverse event in different time periods relative to immunization. With this approach we evaluated temporal associations between MMR immunization and 5915 different diagnoses occurring in the cohort. In order to evaluate the ability of our approach to detect signals, we singled out a set of four adverse events previously recognized as being associated with the MMR vaccine. Results: We were able to link a total of 3 162 251 hospital contacts and 5915 different diagnoses to the children in the cohort. Previously recognized temporal associations between adverse events (febrile convulsions, idiopathic thrombocytopenic purpura, lymphadenopathy and rash) and MMR immunization were identified in the Danish databases by our method. Conclusions: Data mining in the Danish population-based healthcare databases provides adequate ability to detect adverse events. Pharmacovigilance using electronic healthcare databases holds potential as an important supplement to traditional pharmacovigilance. © 2010 Adis Data Information BV. All rights reserved.


Wilson N.M.,Copenhagen University | Laursen M.,Danish Medicines Agency | Lidegaard O.,Copenhagen University
Acta Obstetricia et Gynecologica Scandinavica | Year: 2012

Background. Oral contraceptives (OC) are the most popular contraception in Denmark. Overall figures on use are well described, but more detailed use patterns according to type and age need to be updated. Objectives. To assess trends in the use of OC including progestogen-only pills among Danish women in 1998-2010 and to describe in detail use patterns in 2010. Design. Annual cross-sectional prescription statistics. Setting. Denmark. Population. Danish women 10-49 years old. Material and methods. Analysis of prescription data from the National Registry ofMedicinal Products Statistics from 1 January 1998 through 31 December 2010. Results. Combined OC (COC) with 50 μg estrogen decreased their market share from 3% in 1998 to zero in 2010, and COC with 30-40 μg estrogen decreased to 50% in 2010, in contrast, COC with 20 μg estrogen increased to 46% in 2010. Progestogen-only pills accounted for 4%. COC with levonorgestrel decreased, while the use of pills with desogestrel and gestodene among two-thirds of current users was constant. Conclusion. Low-dose COCs gradually replaced middle-dose pills. Pills with newer progestogens are used primarily by youngwomen, and 85% of users in 2010were on products with desogestrel, gestodene, drospirenone or cyproteroneacetate. We still need low-dose pills with 1st and 2nd generation progestogens on the Scandinavian market. © 2012 The Authors.

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