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PDA Europe: News and Events

Regulatory News

Feb. PDA Letter: Find out which PDA conference is volunteer Don Elinski’s in this issue’s Volunteer Spotlight. Plus, the India Chapter explores quality and sterility assurance. And find out why your resume may not be generating interviews.

VACCINES & BEYOND (Brussels, Belgium)

April 29-30: The aim of vaccine development is to design a stable product which is safe and efficacious for the intended patient population. Under a Quality by Design approach, product development begins with the establishment of predefined quality objectives. Such quality requirements are built on the basis of proven critical quality attributes (CQAs) & related acceptance ranges. This session will be dedicated to selected case studies from different vaccine manufacturers, showing paths for the achievement of this challenging objective. The focus will be on: (i) identification of potential CQAs through product knowledge and risk- based approaches; (ii) understanding of the relationship between structural features and immunogenicity; (iii) practical implications on specifications settings & process understanding, taking into account the need of periodic updates to incorporate the latest development data throughout the product’s lifecycle – Read More.

Advanced Therapy Medicinal Products (Madrid, Spain)

une 3-4: As ATMPs cover the most recent type of medicinal products of high complexity, there is a clear need to discuss the challenges in product development and in non-clinical and clinical testing. Meanwhile, first products are now moving through the regulatory approval path, and the field is starting to take shape, gradually maturing.
This year’s program will specifically focus on CMC development topics both in early and late development as well as illustrate new technical developments in the field. The Program Committee also intends to select a number of submitted posters for short oral presentation and discussion.
Selected keynote lectures and a series of case studies encompassing a broad range of product types and development approaches will illustrate how ATMPs are currently being developed and tested. Examples will come from both the academic world and industry, and will cover cell therapy, gene therapy, and tissue engineering products. A careful selection of presentations aims to demonstrate ATMP diversity and the different aspects of their application and development. All this should set the stage for exchanging professional experience and new ideas in panel discussions. Read More.

Parenteral Manufacturing (Istanbul, Turkey)

June 24-25: Our conference will provide an update on the most recent developments of Turkey and provides interfaces to international, EU and US regulations with case studies from leading global and domestic companies sharing their expert knowledge. Showing current and new technologies will enable you to manufacture state of the art products.
The conference will be split into two main aspects: Regulation and Technology.

- Our track on Regulation will discuss the local landscape framework compared to international harmonized systems such as PIC/S. It will cover the current discussions in Quality Systems, Inspection requirements and especially focus on future regulation trends in Turkey and worldwide.

- Our track on Technology will give an overview of current quality topics, equipment, infrastructure and devices. It will show the current state of the art technology. Case studies will highlight requests and solutions by describing just finalized projects in Turkey. Read More.

GMP for APIs, a PIC/S-PDA Training Course (Brussels, Belgium)

September 18-19: Regulatory inspectors from PIC/S and members of PDA developed this training course based on ICH Q7, taking into account the latest regulatory developments which impact APIs.
This course will be held by inspectors and industry experts. It will start with an overview and provide background of API regulation. All 19 sections of Q7 will be covered. Inspectors will share observations from API manufacturing sites and there will be plenty of time to discuss in detail how to prepare for an inspection. Course participants will have the unique opportunity to receive answers to their specific questions.
PDA believes there is no better way to get first-hand information about the current best-practice in API manufacturing and all related activities. Be sure to sign up soon, seats are filling quickly!
Who should attend: API manufacturer, production, development, QA, QC functions, engineering – Read More.