In the second half of 1998, a group of industry and pharmaceutical operators discussed the possibility of entering into a direct partnership with the Parenteral Drug Association in order to make this organisation more well known in our country.
After a series of telephone calls, and a restricted meeting held in Milan at Pall Italia in December 1998, a conference was held in Rome on January 15, 1999 at the SIFI SpA headquarters, and it was attended by those who today can be considered the 'founding partners' of the Italian group (in no particular order): Antonino Giannetto of SIFI, Vincenzo Baselli and Carlo Marinoni of PALL Italia, Pier Giorgio Valeri, Stefano Macciò, Giovanni Bini of CTP, Giuseppe Gazzara of Fresenius, Vincenzo Messina of Wyeth Lederle, Vittorio Giromini of Biosol Gambro, Enzo Bucci of Farmabiagini, Raniero D'Ascoli of Baxter/Immuno and James Lyda Vice President of PDA.
A working hypothesis was written on that occasion, with the goal of verifying if Italian operators (who until that time had no initiatives on their own in Italy) would be interested in PDA. The first real action of this programme was the Conference on 'Validation and Risk Analysis in the Manufacture of Sterile Pharmaceuticals, Bulk Drugs and Related Healthcare Products', held in Pisa on June 22 and 23, 1999, with around 140 participants from various countries in attendance.
Although organised under tight time constraints and with limited resources, this event was so successful that it prompted the 'founding members', who had meanwhile increased in number, and PDA, to persevere with their initial hypothesis and plan further initiatives for the year 2000.
Two public events were organised by the PDA Italy interest group and held in Italy in 2000: "A Day with FDA", a workshop held on May 31st in Verona, hosted by Glaxo; and "The Future of Validation - Evolving Requirements for Pharmaceutical Development and Manufacturing" held in Milan on October 10 and 11. It was during those months that, in view of the development of the activity and the consequent increase in interest, it was decided that a meeting would be held on May 30th, on the sidelines of the workshop with FDA, to assess if it would be advisable to formalise the request to establish the 'PDA Italian Chapter'.
This meeting, which ended with signing the formal petition by 23 PDA members operating in Italy, was also attended by Edmund Fry, PDA President, James Lyda, Vice President in charge of the Association in Europe, and Virginia Ventura, Director in charge of the liaison amongst chapters.
A few weeks later, in accordance with the Association's By-Laws, the Board of Directors formally approved the request and officially launched the PDA Italy Chapter.
On the sidelines of the Milan Conference on 'The Future of Validation', the Chapter held its first plenary meeting, during which the 13 members of the Executive and Steering Committees were elected. Two initiatives were held in 2001: a Conference on 'Global Pharmaceutical Manufacturing and Quality Strategies' jointly organised by PDA International and the PDA Italy Chapter on April 5th and 6th in Taormina.
Two round tables, one in Milan and the other in Pomezia, hosted by Sigma Tau, to present and discuss the 'Highlights of the 2001 PDA/FDA Joint Conference' that had been held in Washington from September 10 to 12. Finally, in just over two years of activity, some Chapter members participated in PDA working groups to review and comment on important European regulatory documents such as Annex 15 and the NCF Pharmaceutical Water, allowing the group, for the first time, to contribute to the formulation of documents that are fundamental for the future of the European pharmaceutical industry.
The reasons for having a PDA Chapter in Italy What motivated us to work towards this result? These are the questions that, aside from us, other key players of Italian pharmaceutical life have certainly asked themselves from the moment it became clear that there was a space for an organisation such as the Parenteral Drug Association in our market.
The answers are different but closely related. First and foremost, the primary reason that convinced us to move in this direction at the beginning of 1998 was the profound conviction that PDA could play an important and original role in the evolution of the pharmaceutical industry in Italy.
The reactions, both in terms of interest and participation, from the pharmaceutical world were very positive from the outset, thus reinforcing this conviction. This has certainly been helped by the fact that PDA is an organisation that is relevant and prestigious, and it is recognised all over the world, even though its presence is significant mainly in the USA, where it was founded over 50 years ago and where its 'headquarters' is based. It is also expanding its activities in Europe after having done so in Japan. The second reason is related to the importance we give to the work that qualified associations, such as ours, can and must do to contribute to the educational development and evolution of the mentality of the pharmaceutical sector operating in Italy, which can simply no longer escape the challenges imposed by globalisation without risking heavy downsizing.
By now, some three years after the start of our activity, this aspect appears even clearer, and, it would seem, shared in light of what emerged in the meetings we organised with ISPE and AFI. Last, but certainly not least, is the possibility that PDA offers operators in the pharmaceutical world the possibility to participate as protagonists, thanks to the international work groups, in the decision-making processes related to the new European and American regulatory documents that, thanks to mutual recognition, will have 'global' relevance. Therefore, under the current conditions, we believe we can say that PDA will be able to play a truly useful special role in the technological development of our country's pharmaceutical sector. The goal can and must now become much more ambitious by populating the premises with real content. There are two open fronts: the technological evolution and the consequent regulatory adaptation in which the Work Groups coordinated by the Steering Committee members will have to engage. Finally, the challenge should not only concern Italy, but above all Europe, where PDA, thanks to the regular and structured activity of its Chapters, will be able to play a fundamental role as a point of reference for the Regulatory Organisations of our Continent.
PDA: Character and purpose PDA is an international non-profit organisation of 10,000 scientists and other members dedicated to the development of pharmaceuticals and related products, their manufacturing, quality control and regulation. The Association's mission is to aid the advancement of pharmaceutical technology by promoting professional education based on practical and scientifically accurate technical information for the industry and regulatory agencies. A Board of Directors consisting of volunteer members is the governing body of the Association, and it is managed by a professional staff comprised of senior officials with knowledge of both the industry and its regulations. PDA's headquarters are located in Bethesda, Maryland, near Washington, DC, in the District of Columbia.
To assist European members, PDA also has a staff in Basel, Switzerland, while eight other international PDA sections are located in Europe, Asia, Canada and Israel. PDA: member support PDA organises global conferences, symposia and forums aimed at the pharmaceutical industry to enable manufacturers, suppliers, academics and regulatory officials to discuss issues and topics of common interest. These exchanges of knowledge and expertise serve to boost the advancement of pharmaceutical technology and science for the benefit of public health. PDA-sponsored conferences include an annual conference in the United States, international congresses in Europe and Asia, and specialised scientific forums and symposia around the world. In Italy, the PDA Italy Chapter was established in 2000 and has about four events per year. Together with FDA, PDA sponsors an annual PDA-FDA Joint Conference as well as other conferences with FDA and other regulatory bodies in this field.
