Medicon Valley Drug and Device Development link guide

 

CHAPTER 3: APPROACHING CHEMISTRY, MANUFACTURE AND CONTROL (CMC)

 

> p. 24

FDA: www.fda.gov

 

 

CHAPTER 4: APPROACHING NON-CLINICAL DEVELOPMENT

 

> p. 27

M3 document: www.emea.eu.int

 

 

CHAPTER 5: APPROACHING EARLY CLINICAL DEVELOPMENT

 

> p. 40

www.ich.org (CTD, Quality, M4Q)

 

 

CHAPTER 6: REGULATORY AFFAIRS

 

> p. 53

Legal requirements and guidelines for pharmaceuticals

Medical Products Agency in Sweden (Läkemedelsverket): www.mpa.se

Danish Medicines Agency (Lægemid­delstyrelsen): www.dkma.dk

European Medicines Agency (EMEA): www.emea.eu.int

European Medicines Agency (EMEA) is a decentralised body of the Euro­pean Union with headquarters in London.

FDA: www.fda.gov

ICH: www.ich.org

To be updated on regulatory matters these are useful links:

Danish Medicines Agency’s newslet­ter, ‘NetNyt’ - subscribe here

News from Medical Products Agency in Sweden - read more

News from EMEA - read more

European Commission, Enterprise and Industri DG, Pharmaceuticals Unit - read more

News from FDA - read more

 

> p. 54

Legal requirements and guidelines for medical devices

http://europa.eu.int/comm/enterprise/medical_devices

http://europa/eu.int/comm/dg03/directs/dg3/d2/meddev/md/dirmd/dirmd/html

www.fda.gov/cdrh/index.html

www.mpa.se/medicinteknik.html

www.medicinskudstyr.dk

 

> p. 56

Applications

Many applications – around 50% in Denmark – are refused because of incorrectness, despite the fact that user-friendly manuals are published on the authori­ties’ homepages (source: www.dkma.dk)

Application forms and instructions for clinical trials in Denmark - read more

Application forms and instructions for clinical trials in Sweden - read more

 

 

CHAPTER 7: EDUCATION AND NETWORKS IN MEDICON VALLEY

 

> p. 64

 

Education and courses

The Danish University of Pharmaceu­tical Sciences – MIND Programme

www.dfuni.dk/index.php?id=1126

 

Lund University Center for Research on Pharmaceuticals (Läkemedelscen­trum)

www.lmclu.lu.se/research/index.asp

 

The Swedish Academy of Pharmaceu­tical Sciences

www.lakemedelsakademin.se/index.html?page=lma&id=6

 

Medicademy

www.lif-uddannelse.dk

 

Networks and other activities

Medicon Valley Alliance Drug Devel­opment Network

www.mva.org/composite-925.htm

 

Medicon Valley Alliance Biostatistics Network

www.mva.org/composite-42.htm

 

New Safe Medicines Faster (NSMF)

www.nsmf.org