Courses and events progression pathway

Regulatory affairs career progression pathway graphic

 

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Consolidate your regulatory competencies

Courses at this level are for experienced professionals committed to developing their regulatory and management competencies.
Begin DateTitleDescription
19/05/2022CRED Successful and Skilful CommunicationSkilful communication and negotiation skills are essential for effective regulatory professionals. Learn to recognise and use different negotiation strategies whilst maintaining trust and respect with complex groups of stakeholders. Develop and deliver impactful presentations and documents that deliver the results you need.COMM0522
07/06/2022CRED Regulation of Drug Device Combination ProductsAre you developing new pharmaceutical products? Do they include (or are they provided with) any type of administration device?  If yes, are you fully aware of the impact of the Medical Device Regulations on MAAs which came into effect in May 2021?  - This course will explain the current stage of developments as MAHs prepare for the new requirements.DRUG22O
07/06/2022CRED Regulation of Drug Device Combination ProductsAre you developing new pharmaceutical products? Do they include (or are they provided with) any type of administration device?  If yes, are you fully aware of the impact of the Medical Device Regulations on MAAs which came into effect in May 2021?  - This course will explain the current stage of developments as MAHs prepare for the new requirements.DRUG22
14/06/2022CRED Successful and Skilful CommunicationSkilful communication and negotiation skills are essential for effective regulatory professionals. Learn to recognise and use different negotiation strategies whilst maintaining trust and respect with complex groups of stakeholders. Develop and deliver impactful presentations and documents that deliver the results you need.COMM0622
28/06/2022CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical.VAR22
28/06/2022CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical.VAR22O
01/09/2022CRED Understanding Digital Health and Electronic ProductsRegulation on electrical, electronic and software medical devices.EE22
01/09/2022CRED Understanding Digital Health and Electronic ProductsRegulation on electrical, electronic and software medical devices.EE22ONLINE
20/09/2022CRED An Overview of Regulatory Product InformationThis one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.SMPC0922O
20/09/2022CRED An Overview of Regulatory Product InformationThis one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.SMPC22
21/09/2022CRED Project Management for Regulatory Affairs ProfessionalsA two-day, skills-based course on the theory and practice of managing project teams to produce optimal regulatory documents and communications for those working in the pharmaceutical industry.PM0922O
21/09/2022CRED Project Management for Regulatory Affairs ProfessionalsA two-day, skills-based course on the theory and practice of managing project teams to produce optimal regulatory documents and communications for those working in the pharmaceutical industry.PM22
05/10/2022CRED Getting the CMC Dossier RightThis course workshop led by agency and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information in Module 3 of the regulatory dossier. This course will focus on synthetic molecules.CM2210O
05/10/2022CRED Getting the CMC Dossier RightThis course workshop led by agency and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information in Module 3 of the regulatory dossier. This course will focus on synthetic molecules.CMC22
26/10/2022CRED Understanding Clinical DevelopmentThis two-day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I through phases II, III and even clinical trials considerations beyond drug marketing approval.CD22
26/10/2022CRED Understanding Clinical DevelopmentThis two-day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I through phases II, III and even clinical trials considerations beyond drug marketing approval.CD22O

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