Product Types

The importance of effective regulatory affairs and pharmacovigilance training cannot be overemphasised. In particular it is increasingly expected that members of the regulatory affairs and pharmacovigilance functions should have appropriate training records for scrutiny during GCP, GMP and pharmacovigilance inspections.

Regulatory affairs executives need to be familiar with legislation and procedural matters as well as having the skill to recognise potential pitfalls in the scientific data.  All personnel handling pharmacovigilance data need to be fully aware of their obligations concerning the processing of safety information.

Wainwright Associates designs training programmes to meet clients' specific requirements. From one-to-one training of individuals or small groups to complete seminars, we can help improve your regulatory affairs and pharmacovigilance operations and your compliance with legislation and guidance.

This service is offered based on immense experience working on projects for client companies worldwide, much of it in a problem-solving capacity. Regulatory affairs and pharmacovigilance are not only sciences but also arts and we are pleased to share our knowledge.

Individual Training

Nothing is more effective than one-to-one training particularly when new or inexperienced people join the team. Small or very busy departments are particularly vulnerable where there is no-one or no time to carry out the training.

Regulatory affairs training is essential for those involved in day to day registration projects. It is also highly valuable for those who work closely with this team. With a basic understanding scientists who generate reports are better able to create texts which meet the authorities' criteria and administrators can provide a much higher level of support.

The requirements for handling safety data are very prescriptive and it is expected by the authorities that any staff involved in the receipt and processing of adverse events should be appropriately trained, including periodic ‘refresher' training. This also includes sales representatives, medical information and administrative teams.

Training programmes can be tailored to your specific requirements and to meet your budget and can either be intensive courses arranged off-site to maximise benefit and minimise interruptions, or we can work with your member of staff in-house using real projects as the training material. In this way the trainee spends less time away from productive work. Our expert(s) can also be available on an ad hoc basis at the end of a telephone to answer queries as and when they arise or provide relevant advice.

Let us know your training requirements and we will be pleased to propose a suitable package.

In-House Seminars

Seminars designed by Wainwright Associates for presentation in clients' own offices can be held in any location of the world.

The topics are selected, after a thorough briefing, to match exactly the requirements of the company and the intended audience. Speakers are provided from the Wainwright Associates team or, if required, external speakers can be used to cover highly specialised subjects.

In this way, specific training of a whole group can be achieved, with lectures, parallel discussion groups and/or workshops according to demand.

All the technical aspects are taken care of by Wainwright Associates. The programme is written and agreed with the client; speakers are sourced and provided; visual aids and course notes are created. All the client has to do is set the date, arrange the venue, equipment and refreshments; and ensure the attendees are present on the day.

Customised seminars are ideal for groups of up to 30 or 40. They present a perfect opportunity for teams from different departments and/or subsidiaries to hear a consistent message from an independent source.

The Wainwright Associates training service offers several options: a one-off lecture; a 1-2 day seminar or up to a full week's training course.

All we need to design an appropriate seminar is a detailed brief of your company's business, the likely attendees and their level of experience and the immediate concerns you wish us to address.