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Pharmacovigilance on the Internet and Social Media MasterClass

14 September - 16 September

Training OverviewThe direct interaction between patients / users of pharmaceutical products and the Pharmaceutical Companies has had a big increase since the widespread use of the Internet and social media. In parallel, the requirements of the competent authorities towards the exhaustive collection and management of any adverse events related to the products marketed by the…

How to submit variations in Europe MasterClass

16 September

Training OverviewVariations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will learn to define the best submission strategy,…

CAPA and Root Cause Analysis MasterClass

21 September - 22 September

Training OverviewIn today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) and RCA system. This course will cover CAPA and RCA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA…

Unlocking the Potential of Cell & Gene Therapies MasterClass

23 September - 24 September

Training OverviewNowadays, for as much as 95% of the 7 000 to 10 000 rare diseases that exist, there are no approved therapies. Of the estimated 400 M people worldwide afflicted with a rare disease, 50% are children. Cell and gene therapies have emerged as a new treatment paradigm for many rare diseases. These novel…

Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

23 September - 24 September

Training OverviewThe introduction of the Quality by Design concept in the early 2000’s has changed the paradigm of product and process development for recombinant biotherapeutics, switching from the process makes the product to the product makes the process. The Quality by Design approach starts by the understanding of the impact of changes in quality attributes…

US Healthcare & Smart Pharma Packaging – Regulations & Technical MasterClass

12 October - 14 October

Training OverviewThe training course will support you in collecting, sorting and proper understanding of the requirements of pharma and healthcare packaging, the US Healthcare and Pharma Market, the global serialization requirements in the US, in Brazil, Russia, Europe and other markets and the technical implementation at the pharmaceutical manufacturer. This course will deal with Child…

Advanced CMC MasterClass

20 October - 21 October

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…

The EU Clinical Trial Regulation MasterClass

21 October - 22 October

Training OverviewThe new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines…

International Negotiations in Pharma MasterClass

21 October - 22 October

Training OverviewThis 2 day intensive practical programme is aimed at participants who wish to enhance their negotiating skills to master the art of negotiating for a range of legal negotiations, including one-on-one and team - on- team negotiations, negotiations with multiple partners, and one-off and continuing negotiations, also negotiating with more powerful counterparts. Learning Outcomes:…

Advanced Stability Testing of Pharmaceuticals MasterClass

26 October - 29 October

Training OverviewThis public training course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life. Who should attend? The course will provide practical advice for chemists and pharmacists in the pharmaceutical industry as well as in…

All you need to know to generated a valuable genetically engineered model MasterClass

04 November - 05 November

Training OverviewIn this MasterClass, the different steps that are requiered to generate a pertinent genetically engineered model will be detailed and explained. What is the purpose of a specific design? What does a conditional model mean? Is it better to fuse a reporter in N- or C-term of a protein? Should we use IRES (Internal…

Vendor/CRO Management and Oversight MasterClass

04 November - 05 November

Training OverviewWith regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project and manage them efficientlyandeffectivelywillhelptoensurecompliancewiththeregulator’sexpectations. On this course…

Process Validation for Biotechnological Products MasterClass

08 November - 10 November

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…

US Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

10 November - 11 November

Training OverviewIt is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at…

The OECD Principles of Good Laboratory Practices (GLP) MasterClass

16 November - 18 November

Training OverviewThe understanding, development, implementation, follow-up and improvement of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. The GLP Principles are mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals…

Regulatory and Technology Considerations for the Design of Medical Device Software MasterClass

16 November - 18 November

Training OverviewMedical device manufacturers have in recent years expanded their product portfolio with digital solutions and added connectivity to their previously standalone devices. Regulatory bodies have kept the pace and updated their regulations to reflect this new reality. What do these new regulations mean for manufacturers making their move into the digital world? When is…

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

17 November - 18 November

Training OverviewIt is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at…

Process Validation for Biotechnological Products MasterClass

18 November - 19 November

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…

Advanced CMC MasterClass

22 November - 24 November

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…

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

25 November - 26 November

Training OverviewTo ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks, regulatory agencies have developed specific processes to speed the availability of new therapies, especially when there are no satisfactory alternative therapies, while preserving appropriate standards for safety…

Signal and Risk Management in Pharmacovigilance MasterClass

25 November - 26 November

Training OverviewThe focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor’s point of view in evaluating an RMP. The…

The EU Clinical Trial Regulation MasterClass

25 November - 26 November

Training OverviewThe new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines…

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The EU Clinical Trial Regulation MasterClass

16 December - 17 December

Training OverviewThe new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines…

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