• Individual training of regulatory affairs staff
• Customised in-house seminars on regulatory topics

The importance of effective regulatory affairs training cannot be overemphasised for various personnel within the pharmaceutical industry.

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.

The scientists generating the laboratory data need to be able to conduct and report the work to standards that will satisfy the authorities.

The secretarial and administrative team can provide more effective support if they too understand the basics of regulatory affairs.

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 the effectiveness of your regulatory affairs operations.

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

Individual Training

There is nothing more effective than one-to-one training, particularly when a new or inexperienced member of staff joins the team. Small and very busy departments are particularly vulnerable where there is no person or time available to carry out the necessary 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 of regulatory affairs the scientists responsible for generating reports are better able to create texts which meet the authorities' criteria and secretaries and administrators can provide a much higher level of support.

Training programmes can be tailored to your specific requirements and to meet your budget. You can choose a concentrated period of instruction or spread the training over an extended timescale on a 'little and often' basis. Intensive training courses can be arranged off-site to maximise benefit and minimise interruptions.

Alternatively, our trainer can work side by side 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 are designed by Wainwright Associates for presentation in clients' own offices. 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 clear brief of your company's business, the likely attendees and their level of experience and the immediate concerns you wish us to address.