Seminar on Leadership and Team Developm...
Overview: Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in leading your team.. And teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence. Why should you atten...
Webinar on International Evidence Requi...
Overview: Stephen Hull, a 20 year veteran of medical device reimbursement will provide first hand insight into the core requirements of key global markets and offer advice on how to best assemble your global evidence strategy. Detailed slide materials will provide the frameworks and pathways for reimbursement across the target markets. The session will also describe the latest developments in new requirements or hurdles posed in each market. W...
Seminar on Presentation Skills for Tech...
Overview: Presentation Skills for Technical Professionals is a hands-on workshop that helps participants become comfortable, confident, and masterful presenters. The principles presented will be applicable to all business settings. Course content will be customized to focus on the interests and concerns of all attending. Participants will be given practice exercises designed specifically for them. They will have the opportunity to make several...
Seminar on Supplier Management for Medi...
Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, mana...
Seminar on Writing and Enforcing Effect...
Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the...
Regulatory Affairs aspects of clinical...
Course "Regulatory Affairs aspects of clinical trials and clinical Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider....
Seminar on Product Information for Medi...
Overview: Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment. The PL reflec...
GMP Compliance for Pharmaceutical Quali...
Overview: This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requir...
Seminar on GMP Compliance for Pharmaceu...
Overview: This course will present the regulations and guidelines that apply to operations in quality control testing laboratories. In some cases these will not be specific regulations, but needs that, if met, will increase the efficiency or quality of activities in the laboratory. While it will not be possible to cover all of the subtle variations among regulatory regions, general internationally accepted practices that comply with GMP requir...
Webinar on Product Information in the EU
Overview: In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. Why should you Attend: Pr...
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