|Karin Liltorp||Nina Aabenhus Kromann|
|(Ph.D., Senior CMC specialist)|
Phone: +45 22260344
|(M.Sc.,Senior CMC specialist) email@example.com
Phone: +45 3018 7053
|Senior CMC expert with extensive insight in drug development, including analytical aspects as well as regulatory requirements. Strong business focus: The goal is to match the customers needs in relation to quality/analysis versus costs. |
Special expertise in solid state characterization of drug substances.
|Senior CMC expert with extensive experience within requlatory CMC requirements for small molecule as well as biological drugs.
Vast experience in communication and collaboration across functions as well as across cultures.
Focus on the customers needs, and matching the risk profile of the individual customers.
|Experience in brief:|
• Responsible for CMC documentation for a number of marketed drug products.
• Scientific project leader for a large validation program: Defining strategy, optimizing validation work and securing implementation in a complex organization.
• Responsible for business development and building up a GMP laboratory in a new area (solid state characterixation).
• Previously employeed at Particle Analytical ApS, Lundbeck (R&D) and Frederiksberg Hospital (clinical chemist)
• Special expertise in solid and semi solid formulations and in silico simulations (computer simulations of behaviour of drugs in vivo).
• Analytical expertise in XRD, DVS, FTIR, Particle Size determination, DSC, TGA, HPLC, Microscopy, etc.
• CMC responsible, securing all requirements, from API production to final packaging - including responsiblity for drafting of IMPD/IND.
• Lean coach. Main focus on optimisation of cross sectional information flow.
• Ph.D in physical chemistry with focus on protein stability
• Lectures at various workshops and conferences
|Experience in brief
• Facilitate regulatory strategic decisions incl. application procedures, reference member state etc.
• Project management of e.g. compilation and review of Module 3 and QoS for EU+, Canada, Japan, China and US applications.
• Responsible for conducting scientific advice with authorities.
• Collaboration across cultures and functions - extensive experience working with customer partners and CMOs/subsidiaries of different nationalities (e.g. US, Japan, China, Spain).
• Previously employeed at ALK-Abello for 14 years (8 years as regulatory specialist)
• Manager in Development initiating a new GMP laboratory building bridge between the production and development areas.
• Facilitate decisions through risk assessments on e.g. strategies for content of regulatory applications as well as responses to authority questions (ASMF/DMF, clinical trial applications, marketing authorisation applications and variation applications).
• Technical writing and regulatory review of regulatory sections, development