. ICH Q7 WEEK .
The APIC "the Active Pharmaceutical Ingredients Committee" is a Sector Group within Cefic (the European Chemical Industry Council).
Objectives of the APIC
- To represent the interests of pharmaceutical and chemical companies producing APIs and intermediates globally by being recognized experts who advance and influence the global GMP and Regulatory environment.
- To promote the use of compliant APIs in medicinal products to ensure patient safety.
Major Strategic Objectives, such as.:
- To strongly advocate regulatory compliance in all global markets and its enforcement through inspection.
- To support global harmonisation in the fields of quality and regulatory affairs.
- To be the forum where API manufacturers discuss GMP, RA and other technical issues that affect their business.
Cooperation and Contacts:
In order to achieve its mission APIC is in regular contact with national and intergovernmental bodies, such as:
- European Commission (EC)
- European Medicines Agency (EMA)
- European Directorate for the Quality of Medicines & Healthcare (EDQM)
- European Parliament (EP)
- US Food and Drug Administration (FDA)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- World Health Organization (WHO)
- Council of Europe (CoE)
- Pharmaceutical Inspection Cooperation Scheme (PIC/S)
The ECA Academy is the educational organisation of the ECA Foundation (please see www.eca-foundation.org for more information). It develops and organises a wealth of international education courses, conferences (also as part of a GMP Certification Programme) and webinars around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc., European conferences are organised as discussion forums on new trends and developments.
The Academy is supported by the ECA Foundation Advisory Board. This Board acts as conceptual sponsor in the development of new courses and conferences and ensures best quality and participant satisfaction by evaluating all events. As the Foundation does not employ own staff all services offered by the ECA Academy and with regard to ECA Academy Memberships are solely managed by Concept Heidelberg, a leading professional European training and information services provider in the pharmaceutical industry environment (please see www.concept-heidelberg.com for further information).
In addition to the ECA Academy the Foundation also runs a number of non-profit working and interest groups. These are:
- The European Qualified Person (QP) Association
- The Pharmaceutical Microbiological Group
- The Analytical Quality Control Group
- The Validation Association
- The Good Distribution Practices (GDP) Association
- The Visual Inspection Group
- The Data Integrity & IT Compliance Group
- The ATMP Group
- The Cannabis Group
As Europe’s leading advanced training and information services provider in this area CONCEPT HEIDELBERG develops and organises more than 300 seminars and conferences in 11 European countries.
CONCEPT HEIDELBERG has been entrusted by APIC/CEFIC to organise the ICH Q7 Week. This event is co-sponsored by the ECA Academy. (www.gmp-compliance.org).
For more information about CONCEPT HEIDELBERG, please vitsit: www.concept-heidelberg.com