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 National Health Surveillance Agency (ANVISA) is pleased to host the 2024 PIC/S Seminar on “New Annex I of Sterile Products” in Brasilia (Brazil) from 6-8 November 2024, 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The outcome of Seminars usually results in the formation of a Working Group to develop a draft Guidance or Recommendation.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 |
| 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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