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Event Archive

PPS Career Highlights

"Technical and Regulatory Challenges for Validation", Istanbul, Turkey

At this Training, we have specially designed interactive lecture sessions focussing on the importance of conducting validation studies as specified by European Regulatory Authorities. The program will have TWO Hands-On Workshops, on practical issues related to Pharmaceutical Manufacturing Processes and Utilities. Also at this program, for the FIRST TIME out of Europe, we would be covering the most important aspects of GAMP 5 and Computer Validation, the guidelines that have been just released in Europe.

Technical and Regulatory Challenges for Validation


"CTD : Challenges for Industry, Amman, Jordan"

The Common Technical Document (CTD) is the most important document for obtaining regulatory approvals in EU and US. Understanding the current Jordanian industry moving towards EU markets, PPS brings you the regulatory expertise of US Speakers with Hands-On experience in the field of CTD and electronic filing. This program is a must attend for all personnel for Regulatory, Documentation and Quality Affairs departments.

CTD : Challenges for Industry, Amman, Jordan


"cGMP Systems : Trends and Technologies"
2-3 September 2007, Alleppo
5-6 September 2007, Damascus

Spurred on by the success of the last event held in the Middle East, Prescription Pharma Support presents another training workshop, "cGMP Trends and Technologies" , this time to be held at TWO VENUES in Syria, for the local industry in Alleppo and Damascus. This event is held in conjunction with the Scientific Council, Ministry of Health in Syria. The scientific program is tailor-made to suit the preferences of the fast-growing Pharma Manufacturing industry in Syria, who are currently in the process of upgrading their facilities and moving towards more compliance towards European norms, as well as GMP according to the directive by the Ministry of Health. Based on the feedback received at the previous event; this training will be oriented towards more real-life situations, case studies and practical problem solving sessions, focusing more on the Quality, Regulatory and Manufacturing aspects of cGMP Systems.

cGMP Systems : Trends and Technologies


Regulatory Submission Procedures for EU – API and Drug Products
4-5 May 2007, Hotel Taj Banjara, Hyderabad

This conference was held jointly with Pharma Institute of GMPs and EDQM in Hyderabad, India, where FIVE of the heads of different departments addressed around 125 personnel of the Indian Pharma industry on the regulatory requirements and Processes for Certification from the EU. There was another feature that aroused interest in this program; One-to-one sessions. These were meetings held between members of the EDQM and senior representatives of the industry, to discuss specific (and confidential) issues of the organizations involved. This concept, introduced for the first time in India, received much applause and appreciation for its benefits to the industry.

Regulatory Submission Procedures for EU – API and Drug Products

“INDO-EURO API FORUM” at BASEL, Switzerland
13-14 Nov 2006, Basel, Switzerland

Prescription Pharma Support's first venture abroad was the INDO-EUROPEAN API FORUM 2006, held at Basel, Switzerland, on 13-14 November 2006. The program, jointly held with Pharma Institute of GMPs, was a bid to create a common platform between the European and Indian, industry and regulators, with specific emphasis on the API and Generic Pharma business, considering the fact that almost 50% of APIs in Europe are outsourced, and India is among the one of the largest sourcing hubs.

Mr. Gautam Maitra, Swiss Society for Pharmaceutical Sciences, was the Co-Chairman of the Scientific Session along with Dr. Sumant Baukhandi, Pharma Institute of GMPs. The European regulators were represented by Dr. Agnes Artiges, Dr. Corinne Pouget, EDQM, and Mr. Michel Keller, PIC/S, SwissMedic. Their Indian counterpart from the regulatory arena was Mr. Suhas Chaudhari, Jt. Commissioner, FDA, Maharashtra, who was joined by Dr. Sumant for the industry perspective. Dr. Georgios Imanidis conducted a special technology session on HIV and Drug Delivery Systems.

The event was well attended by companies from Switzerland, Germany, Denmark and Netherlands to name a few.

“INDO-EURO API FORUM” at BASEL, Switzerland