Seminars are hosted each year by a different PIC/S Participating Authority. Each Seminar focuses on a particular aspect of GMP with the aim of providing training and harmonisation in the field covered. Annual PIC/S training Seminars are open to Inspectors from PIC/S Participating Authorities and other interested Medicine Regulatory Authorities. Seminars are not open to Industry.
The Pharmacy and Poisons Board of Hong Kong (PPBHK) and the Department of Health (DH) will be hosting the 2025 PIC/S Seminar in Hong Kong (SAR) from 5 to 7 November 2025, preceded by the PIC/S Committee meeting.
The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.
PIC/S Seminars last for 2.5 days and are attended on average by more than 100 Inspectors from all over the world. All participants must pay for their own costs (registration fee & accommodation).
Seminars are not profit-oriented. They are organised by Regulatory Authorities for Regulatory Authorities in line with the PIC/S Aide-Memoire on Organisation of Seminars. Industry cannot attend as such PIC/S Seminars except as invited speakers. Most presentations are given by active Inspectors while only a few are given by speakers from other fora (university, organisations, industry, etc.).
The outcome of Seminars usually results in the formation of a Working Group to develop a draft Guidance or Recommendation. For example, the 2004 Seminar on Active Pharmaceutical Ingredients (APIs) resulted in the preparation and the issuing of the PIC/S Aide-Memoire on the inspection of APIs.
PIC/S Participating Authorities have hosted Seminars since 1971. The following list offers an overview of Seminar topics and hosts over the years.
Year |
Topic |
Host |
2024 | New Annex I of Sterile Products | Brasília | Brazil |
2023 | Soft Skills that Make a Good GMP/GDP Inspector in 2023 | Bangkok | Thailand |
2022 | Inspecting the Pharmaceutical Quality System (PQS) | Dublin | Ireland |
2021 | GMP Assessment Approaches in Post COVID-19 Era | Virtual | Republic of Korea |
2020 | Distant Assessment of GMP Compliance | Virtual | Finland |
2019 | Quality Assurance of Sterile Medicinal Products - Annex 1 | Toyama | Japan |
2018 | Management of Risk through the Product Life-Cycle | Chicago | USA |
2017 | Quality Control Laboratories: How to Inspect | Taipei | Chinese Taipei |
2016 | Inspectorates of the Future | Manchester | UK |
2015 | Biopharmaceuticals (Biotechnology and Biologicals): How to Inspect | Nusa Dua | Indonesia |
2014 | Dedicated Facilities: Yes or No | Paris | France |
2013 | Global Supply Chains and GMP Compliance | Ottawa | Canada |
2012 | Qualification and Validation: Today and Tomorrow | Kiev | Ukraine |
2011 | Good Pharmaceutical Inspection Practices | Cape Town | South Africa |
2010 | GMP Inspection of Manufacturers of Traditional / Herbal Medicinal Products | Kuala Lumpur | Malaysia |
2009 | Inspection of Aseptic & Sterile Manufacturing from APIs to finished dosage forms | Uppsala | Sweden |
2008 | Good Distribution Practices | Krakow | Poland |
2007 | The Inspection of the Manufacture of Solid Dosage Forms | Singapore | Singapore |
2006 | Quality Risk Management and related ICH topics | Düsseldorf | Germany |
2005 | Primary packaging material, labelling and the prevention of mix-ups (including counterfeit packaging and labelling) | Bucharest | Romania |
2004 | The Inspection of Manufacturers of Active Pharmaceutical Ingredients | Barcelona | Spain |
2003 | The Inspection of Quality Control Laboratories | Bratislava | Slovak Republic |
2002 | The Interface Between Good Clinical Practice (GCP) and GMP in the Manufacture and Audit of Clinical Trial Products | Montebello, QC | Canada |
2001 | Utilities Used by the Manufacturer of Pharmaceuticals | Prague | Czech Republic |
2000 | The Inspection of Products derived from Biotechnologies | Colmar | France |
1999 | Non-Technical Aspects of Inspection | Oxford | United Kingdom |
1998 | Quality Systems for Pharmaceutical Inspectorates | Zeist | Netherlands |
1997 | Manufacture and Inspection of Active Pharmaceutical Ingredients | Naantali | Finland |
1996 | GMP Standards for Active Pharmaceutical Ingredients | Canberra | Australia |
1996 | Inspection of Computer Systems | Sydney | Australia |
1995 | Inspecting the Manufacture of Sterile Products - Current and Future Trends | Hveragerði | Iceland |
1994 | Qualification and Validation in Pharmaceutical Manufacture | Dublin | Ireland |
1993 | The Role of Inspection and Testing in relation to the Marketing Authorisation | Louvain-la-Neuve | Belgium |
1992 | New Aspects of Products Derived from Biotechnology | Montecatini Terme | Italy |
1991 | Audit - Pharmaceutical Inspection | Felsötárkány | Hungary |
1990 | Blood and Blood Products | Hillerød | Denmark |
1989 | Contamination Risks in the Manufacture of Parenterals | Baden | Austria |
1988 | Water for Pharmaceutical Purposes | Jongny | Switzerland |
1987 | The Business of Pharmaceutical Inspection | Cambridge | United Kingdom |
1986 | Plastics and their Pharmaceutical Applications | Sigtuna | Sweden |
1985 | Premises for Pharmaceutical Manufacture | Oslo | Norway |
1984 | Requirements of Good Manufacturing Practice and Quality Control in the Production of Biological Products | Frankfurt a/Main | Germany |
1983 | Safety Aspects of the Packaging of Pharmaceutical Products | Lisbon | Portugal |
1982 | Validation | Dublin | Ireland |
1981 | Application of GMP Rules in the Control Laboratory | Budapest | Hungary |
1980 | Good manufacturing Practice in the Manufacture of Active Ingredients | Liestal/Basel | Switzerland |
1980 | Inspection in Tablet Manufacture | Copenhagen | Denmark |
1979 | PIC Basic Standards of GMP - Need for Revision? | Helsinki | Finland |
1978 | Large Volume Parenterals | Oslo | Norway |
1978 | Good Manufacturing Practice in Tablet Manufacture | Sunnindale | United Kingdom |
1977 | Modern Methodology for the Isolation, Identification and Quantification of Drugs and Related Substances | Uppsala | Sweden |
1976 | Stability of Pharmaceutical Products | Salzburg | Austria |
1975 | The Manufacturer's Quality Control Department Structural and Functional Aspects | Copenhagen | Denmark |
1974 | Manufacture and Quality Control under Contract | Berne | Switzerland |
1973 | Sampling and Analytical Control | Edinburgh | United Kingdom |
1972 | The Quality of Pharmaceutical Products | Rennes | France |
1972 | Contamination in the Manufacture of Pharmaceutical Products | Stockholm | Sweden |
1971 | Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products | Geneva | Switzerland |
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