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MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies

MDC RegAffairs GmbH is a consultancy company offering services in the field of drug regulatory affairs and drug development.

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MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies | mdc-regaffairs.com Reviews

https://mdc-regaffairs.com

MDC RegAffairs GmbH is a consultancy company offering services in the field of drug regulatory affairs and drug development.

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MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies

http://www.mdc-regaffairs.com/services.html

Projektmanagement in pharmazeutischer Forschung and Entwicklung. Köln, 17./18. März 2016. Der CMC-Manager in Regulatory Affairs. Köln, 2.12.2015 - 4.12.2015. At MDC RegAffairs we are particularly focused on the development and authorisation of drugs for children and orphan drugs as well as European authorisation procedures. Our core expertise is:. Orphan designation in the European Union and the US. Transfer of Orphan Designation. Authorisation of orphan medicinal products.

2

MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies

http://www.mdc-regaffairs.com/orphan_drugs.html

Projektmanagement in pharmazeutischer Forschung and Entwicklung. Köln, 17./18. März 2016. Der CMC-Manager in Regulatory Affairs. Köln, 2.12.2015 - 4.12.2015. Regulation No 141/2000 - the Orphan Regulation (EC/141/2000). Regulation (EC) No 847/2000. Commission Communication (2003/C 178/02). European Commission: Orphan Guideline.

3

MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies

http://www.mdc-regaffairs.com/biosimilar.html

Projektmanagement in pharmazeutischer Forschung and Entwicklung. Köln, 17./18. März 2016. Der CMC-Manager in Regulatory Affairs. Köln, 2.12.2015 - 4.12.2015. EMA Presubmission Procedural Notes (Q&A): Generic/hybrid applications.

4

MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies

http://www.mdc-regaffairs.com/paediatric_regulation.html

Projektmanagement in pharmazeutischer Forschung and Entwicklung. Köln, 17./18. März 2016. Der CMC-Manager in Regulatory Affairs. Köln, 2.12.2015 - 4.12.2015. Reflection Paper: Formulation of Choice for Paediatric Population. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. ICH E11 Clinical investigation of medicinal products in the pediatric population.

5

MDC RegAffairs GmbH | Regulatory | Publications | Databases | Orphan Drugs | Paediatric Regulation | Authorisation | Advanced Therapies (ATMP) | Biosimilar | Agencies

http://www.mdc-regaffairs.com/public_databases.html

Projektmanagement in pharmazeutischer Forschung and Entwicklung. Köln, 17./18. März 2016. Der CMC-Manager in Regulatory Affairs. Köln, 2.12.2015 - 4.12.2015. Centrally authorized products, orphan drug designations). Centralized Procedure: Pending EC Decisions. Heads of Medicinal Agencies). Orphan Drug Designation: Public summary of opinions. Opinions and decisions on paediatric investigation plans and waiver. Drugs authorized in UK: eMC.

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