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Pharma Real-World Evidence MasterClass

02 March - 03 March

Training OverviewReal-World Data (RWD) has become a fundamental tool for the development and demonstration of the value of any new health technology, through the observation of what happens in real clinical practice. Real-World Evidence (RWE) is a key opportunity to better understand the disease, patient needs, and to improve healthcare processes. RWE promises that a…

Medical Device Regulation MasterClass

16 March

Training OverviewIt is the course’s goal to inform about the Medical Device Regulation (EU) 2017/745 coming into force on 26th May 2021 and the UDI-marking requirements in Europe and US. Generally, the challenges and solutions how to comply with the requirements of Medical Devices and Unique Device Identification (UDI) in the different markets are core…

Regulatory and quality requirements for the design and development of Medical Device Software MasterClass

12 April - 14 April

Training OverviewTwenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a…

Process Validation for Biotechnological Products MasterClass

05 May - 06 May

Training OverviewManufacturing processes should be validated prior to initiate commercial manufacturing. Regulatory bodies expect that the manufacturer understand the process so that quality, safety and efficacy of the product are designed or built into the product through the appropriate control of each manufacturing process steps. Today, process validation comprises three main steps: (1) Stage 1…

Development of generics: From R&D to GMP MasterClass

10 May - 11 May

Training OverviewThe interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP…

Smart Packaging and Technical Operations in Pharma MasterClass

11 May - 12 May

Training OverviewThe training course will support you in collecting, sorting and proper understanding of the requirements of the serialisation Requirements in Brazil, Russia, in Europe, the US and other markets. This includes the relevant information related to the Brazilian Serialisation, the Russian Crypto Coding, the defined two EU-safety features (unique identifier and tamper evident closure)…

GxP in Pharma MasterClass

12 May - 14 May

Training OverviewFrom the idea to the patient Since 1231, when Friederich II passed the Constitutione Regni Siciliae, (the first medicinal law for Europe) the regulations for medicinal products have changed. The first chemically synthesized APIs in combination with the industrialization beginning 1900, shifted the production of medicinal products from pharmacies to pharmaceutical companies. Meanwhile we…

Advanced CMC MasterClass

19 May - 20 May

Training OverviewTechnical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products. The course…

Risk-Based Validation of Laboratory Computerised Systems MasterClass

19 May - 20 May

Training OverviewAnalytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument qualification (AIQ) and computerised system validation (CSV). In the current regulatory environment instruments and systems must ensure data integrity and therefore technical controls must be enabled to ensure this…

Best practices and tools for Pharma Project Management MasterClass

20 May - 21 May

Training OverviewProject Management is a managerial discipline - with specific processes, tools and techniques - whose importance is increasingly recognized in the Pharma Industry, expecially in R&D, Development and Sales Functions or Divisions. Managers are increasingly called upon to improve their Project Management skills, in research/discovery, preclinical and clinical studies, filing/approval as well as in…

Benefit-Risk Assessment in Pharmacovigilance MasterClass

27 May - 28 May

Training OverviewThe focus of this training will be on providing an update of ongoing activities regarding the benefit risk assessment throughout the lifecycle of a medicinal product. We will discuss the comprehensive framework on benefit-risk of medicinal products and participants will learn about the main principles, legal, and regulatory basis for benefit-risk obligations and frameworks…

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