Attendees of the course will get an understanding of the quality issues specific to biopharmaceuticals, for example; the generation of a recombinant microorganism, the expression of the product from the microorganisms and its purification, and the regulatory expectations for characterization of a biopharmaceutical product and to release/stability specifications set for these types of products. As process changes are inevitable during development of a biological/biotechnological product this course will provide the implications of changes in the production process and elaborate the concept of comparability.

By the end of this module, the student should be able to:

- understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product - including the critical parts of CMC/Quality sections of the filing dossier, and the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development and for approval of these types of medicinal products

- evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval, prepare regulatory CMC/Quality strategies, consider both FDA and EU aspects throughout the clinical development, and evaluate relevant regulations and guidelines for biopharmaceuticals

- use best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes, when preparing a CMC/Quality meeting with Authorities, and when structuring the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format

The course will besides giving a broad understanding of the specific quality issues for biopharmaceuticals have focus on preparing regulatory CMC/Quality strategies to ensure compliance with regulatory requirements throughout clinical development and post-approval. The discussions of CMC/Quality strategies will consider both FDA and EU aspects and the course will make you aware of both FDA and EU regulatory procedures for approval of biopharmaceuticals. Additionally, the course will take you through the building of the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format also taken submission as eCTD into consideration.

Questions to be answered to during the course:

Course Leaders:

Louise Ploug Berth,
Associate Director, Regulatory Affairs CMC, Genmab A/S, Denmark

Nanna Aaby Kruse,
M.Sc.Pharm, Senior Biological Assessor, Member of BWP, Danish Medicines Agency, Denmark 

Lecturers in 2011 - we expect to be able to employ the same lecturers in 2013:

• John Geigert, Ph.D, RAC, Biopharmaceutical Quality Solutions, US 
• Sandra P. Aguste-Bowler, Regulatory Affairs Specialist, LEO Pharma A/S, Denmark 
• Mayra Latorre-Martinez, Regulatory Affairs Section (Regulatory, Procedural and Committee Support), EMA (The European Medicines Agency), UK
• Anders Nelving, Sweden (former Project manager CMC, Genmab A/S, Denmark)
• Florian Lengyel, Ph.D., M.Sc., Quality Assurance 1 / Regulatory Affairs, Vetter Pharma-Fertigung GmbH & Co. KG, Germany
• Mats Welin, Senior Expert,Swedish Medicines Products Agency, Sweden
• Kowid HO, Biologicals/Biotechnology Unit, AFSSaPS, France
• Niels Kristian Klausen, Senior Project Manager, Protein Chemistry, Biopharm, Novo Nordisk A/S, Denmark
• Nanna Aaby Kruse, M.Sc.Pharm, Senior Biological Assessor, Member of BWP, Danish Medicines Agency, Denmark
• Asser Sloth-Andersen, Manager, Dept. of Protein Expression, Diabetes Research Unit, Novo Nordisk A/S, Bagsværd, Denmark
• Jens Christian Wortmann, Project Director, Project Management at CMC Biologics A/S, Denmark
• Allan Hey, CMO Manager, CMC Biologics, H. Lundbeck A/S, Denmark
• Lisbeth Palm, Senior Project Manager, Biopharm Analytic Development, Novo Noridisk A/S, Denmark

Areas that will be covered:

Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis.

Accomodation (not included in the course fee):
If you need hotel accommodation, we recommend the below hotel where you will get a discounted price.

Hotel Twentyseven
Hotel Twentyseven is located in the heart of Copenhagen, close to the Town Hall Square, the Tivoli Gardens, and Copenhagen Central Station, and airport trains, S-trains, regional trains, and busses leave from the sta­tion regularly. Hotel Twentyseven has a special atmosphere based on unique experiences, living design, seductive comfort, hospitality, and an uncomplicated life. All the 200 rooms in the hotel have been designed in the well-known Scandinavian design tradition by leading Danish designers & architects. www.hotel27.dk 
Fixed prices – breakfast included: Small single room - DKK 930 (approx. EUR 125), Double room for 1 person – DKK 1,080 (approx. EUR 145)

Shuttle Bus - Included in the Course Fee!
Medicademy arrange transportation by bus every day from Hotel Twentyseven in the morning to Medicademy and back again in the evening from Medicademy to Hotel Twentyseven – included in the course fee!

Networking Dinner - Included in the Course Fee!
The networking dinner takes place at Hotel Twentyseven on the first night of the module - February 6, 2013!