Organisation & Contact
The APIC "the Active Pharmaceutical Ingredients Committee" is a Sector Group within Cefic (the European Chemical Industry Council).
Objectives of the APIC
Mission:
- To promote the use of compliant APIs in medicinal products to ensure patient safety.
- To represent the interests of the European API industry worldwide by advancing and influencing the global GMP and Regulatory environment through our expertise.
- To support the sustainability of the European API industry.
Major Strategic Objectives, such as.:
- Networking/ Advocacy: to continually improve our contacts and to increase the profile of APIC with all relevant stakeholders.
- Level Playing Field: to strongly advocate regulatory compliance in all global markets and its enforcement through inspection.
- Post approval change authorisation: to put the responsibility to manage change into the hands of industry.
- Harmonisation: to support global harmonisation in the fields of quality and regulatory affairs.
Cooperation and Contacts:
In order to achieve its mission APIC is in regular contact with national and intergovernmental bodies, such as:
- Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil
- European Commission (EC)
- European Medicines Agency (EMA)
- European Directorate for the Quality of Medicines (EDQM)
- US Food and Drug Administration (FDA)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Pharmaceuticals and Medical Devices Agency (PDMA) in Japan
- World Health Organization (WHO)
- and mostly through the European Fine Chemicals Group (EFCG):
the European Parliament (EP)
To learn more about the APIC, please visit apic.cefic.org.
The ECA Academy is the ECA Foundation’s educational organisation. It has been organising and conducting trainings (educations courses, conferences and webinars) in the GMP and regulatory compliance environment since the ECA was founded in 1999. With close to 3,600 members from more than 60 countries, ECA has become the leading European association with regard to pharmaceutical Quality Assurance and GMP compliance. The independent organisation is chaired by a Scientific Advisory Board with members of the pharmaceutical and biopharmaceutical industry and regulatory authorities. By their voluntary work, the board members support ECA in fulfilling its mission to impart most relevant knowledge on the interpretation and implementation of GMP and regulatory requirements.
To learn more about the ECA Academy, please visit www.gmp-compliance.org.
Concept Heidelberg is Europe’s leading advanced training and information services provider in the area of pharmaceutical quality assurance and drug safety. It is the ECA’s exclusive partner and has been entrusted with managing the complete process. This goes from marketing to the organisation and the registration of all ECA events. Concept Heidelberg is also working for many other not for profit organisations (e.g. Universities and Industry Associations) that do not have own resources for conference management.
To learn more about CONCEPT HEIDELBERG, please visit www.concept-heidelberg.com.
CONCEPT HEIDELBERG GmbH
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