Introduction Workshop programmes at EMWA conferences Booking workshops Foundation and advanced workshops Gaining EPDP credits Pre-workshop assignment The workshop Post-workshop assignment Sending your assignments Credit records EMWA certificates Foundation certificates Advanced certificates Repeating workshops Fees for certificates Workshops currently in the EPDP programme
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EMWA Professional Development Programme Brochure

(Last Updated: February 2018)

Introduction

The EMWA Professional Development Programme (EPDP) provides high-quality training for medical writers through workshops and homework assignments. We run the workshops at our twice-yearly EMWA conferences.

All EPDP workshops are approved by the EMWA Professional Development Committee (EPDC) and are given by people with extensive professional experience in the topic. Most are a mixture of lectures and group exercises, with time for questions and discussion.

EMWA workshops usually have a pre-workshop assignment and all have an assessed post-workshop assignment. If you attend EPDP workshops and successfully complete the assignments you can gain EPDP credits, which can allow you to apply for an EMWA certificate. The element of assessment ensures that EMWA credits represent a real attainment, and are a valuable addition to your CV. Credits are added to your personal EMWA professional development record, which you can view online in your EMWA account as long as you remain an EMWA member.

EMWA credits and certificates demonstrate your commitment to continued professional development. However, an EMWA certificate is not an endorsement by EMWA of a person’s professional competence – that is, EMWA has not ‘certified’ the certificate holder. Holding an EMWA certificate does not entitle you to claim that you are ‘EMWA certified’ or a ‘certified medical writer’ or similar statement.

Workshop programmes at EMWA conferences

EPDP workshops are only available at EMWA’s twice-yearly conferences. As well as the workshop programme, our conferences offer other opportunities for professional development including seminars, plenary sessions, and symposiums. See the conference pages for information about past and upcoming conferences.

Because we have such a wide variety of workshops, we are unable to run all of them at every conference. When we are scheduling workshops for a conference, we try to ensure the programme covers a broad range of topics and offers a balance of foundation and advanced workshops. We also take account of demand for topics at previous conferences.

Workshops are open only to EMWA conference attendees. Conference registration for non-members includes 1 year’s membership of EMWA.

Booking workshops

There is a fee for each workshop, in addition to the conference registration fee (see conference details on the EMWA website).

Workshop places are allocated on a first-come-first-served basis. Some workshops fill up quickly, so it is advisable to register early to avoid disappointment. Booking early will also give you the benefit of the early-bird discount on registering for the conference.

To gain maximum benefit from the conference programme, we recommend you register for a maximum of 4 EPDP credit workshops per conference.

Foundation and advanced workshops

Foundation level workshops are aimed at those who are new to a topic, or who have a moderate level of experience in it. They have a maximum 32 participants and last 3 or 3.5 hours.

Advanced level workshops cover topics that are likely to be of interest to more experienced writers, or deal with foundation level topics in greater depth. There are no formal prerequisites to participate, but leaders will not be able to spend time explaining the basics of the topic to inexperienced participants. The participant profile in the individual workshop description gives details of experience required. Advanced workshops have a maximum of 20 participants and always last 3.5 hours. Some advanced workshops are designated as ‘master classes’. These are highly interactive workshops with a maximum of 12 participants.

There are a few all-day workshops in the programme.

Gaining EPDP credits

Both foundation and advanced workshops can be done to gain EPDP credits. To gain a credit, you must do the pre-workshop assignment (if applicable), attend the workshop, and satisfactorily complete the post-workshop assignment, as described below. If you satisfactorily complete an all-day workshop, you will be awarded 2 credits.

Pre-workshop assignment

After registering for the conference, download the pre-workshop assignment from the EMWA website, complete it (this usually takes up to 2 hours), and submit it to the workshop leader by the deadline given, if applicable. A small number of for-credit workshops do not have a pre-workshop assignment.

If you register for the conference after the deadline for the pre-workshop assignment, you should submit the assignment as soon as you can if you wish to obtain credit. Pre-workshop assignments must be submitted before the workshop. They cannot be accepted after the workshop.

The workshop

To receive credit you must attend the workshop. Participants who miss more than 30 minutes of instructional time (by arriving late, leaving early or leaving the room for a long period) will not be eligible for credit.

Post-workshop assignment

The workshop leader will give you the post-workshop assignment at the end of the workshop or send it to you afterwards.

You must complete the post-workshop assignment to a satisfactory standard, and submit it by the deadline given. It usually takes up to 3 hours to complete a post-workshop assignment, and the deadline is usually about 6 weeks after the conference.

The workshop leader will mark the assignment, let you know whether you have gained a credit, and send you feedback (for example, a model answer or individual comments).

Please note that post-workshop assignments must be your own work. We do not accept joint submissions or submissions based on joint working unless specified by the workshop leader.

Sending your assignments

It is your responsibility to ensure that your assignment reaches the workshop leader. Leaders are asked to acknowledge receipt; if you don’t receive an acknowledgement within a week, you should contact the leader again to check they have received your assignment. Please follow any special instructions for sending the assignment – for example, a specified email address or email subject line.

Credit records

Credits from each conference are collated by EMWA Head Office and uploaded to members’ individual accounts, where they will appear approximately 12 weeks after the conference.

EMWA certificates

You can apply for an EMWA certificate by collecting EPDP credits. You need 8 credits from different workshops to qualify for a certificate. Each EPDP credit can only count once towards 1 certificate. Contact EMWA Head Office to apply for a certificate: email info@emwa.org.

EPDP for-credit workshops are divided into 5 areas of expertise: Drug Development, Language and Writing, Medical Communication, Medical Science and Professional Techniques. There are also some Soft Skills workshops that are not for credit.

EMWA certificates are certificates of achievement in continuing professional development. They are not an endorsement by EMWA of a person’s professional competence – that is, EMWA has not ‘certified’ the certificate holder. Holding an EMWA certificate does not entitle you to claim that you are ‘EMWA certified’ or a ‘certified medical writer’ or similar statement. Appropriate wording would be: 'I have a foundation [an advanced] certificate from the EMWA professional development programme.

Foundation certificates

An EMWA foundation certificate is awarded for 8 credits from foundation workshops as follows:

You may obtain more than 1 foundation certificate after completing the appropriate requirements for each certificate. Certificates list the workshops for which credits have been obtained.

Advanced certificates

An EMWA advanced certificate is awarded for credits in any 8 different advanced workshops (these include master classes run for credit). You do not need to have a foundation certificate to register for advanced workshops.

You may obtain more than 1 advanced certificate after completing the appropriate requirements for each certificate. Certificates list the workshops for which credits have been obtained.

Repeating workshops

If you are awarded a credit for a workshop and then repeat the same workshop within 5 years, you will not get another credit. The only circumstances in which this will not apply will be if the workshop leader has updated the workshop to the extent that a new outline and abstract have been submitted to the EPDC. In this case, credit will be awarded for the updated workshop.

‘Repeating a workshop’ will be defined by the core code for the workshop and not by the additions that indicate a minor variation, such as change in workshop leader or workshop title. For example, DDA10 and DDA10a would count as the same workshop.

We cannot accept workshop credits awarded before November 2009 in applications for certificates, because of the way records were kept historically.

EMWA certificates are certificates of achievement in continuing professional development. They are not an endorsement by EMWA of a person’s professional competence – that is, EMWA has not ‘certified’ the certificate holder. Holding an EMWA certificate does not entitle you to claim that you are ‘EMWA certified’ or a ‘certified medical writer’ or similar statement. Appropriate wording would be: 'I have a foundation [an advanced] certificate from the EMWA professional development programme.

Fees for certificates

An administration fee (currently €100.00) will be charged for issuing certificates. This charge reflects the considerable cost of administering members’ training records. The certificate fee replaces the programme enrolment fee that was previously charged.

Workshops currently in the EPDP programme

Currently active workshops are listed below. Click on the workshop title for full details.

You can also browse the workshop leaders’ biographies.

The codes in the workshop list tell you which area of expertise the workshop covers and whether it is a foundation or advanced level workshop.

Area of expertise covered by the for-credit workshop Foundation Advanced
Drug Development DDF DDA
Language and Writing LWF LWA
Medical Communications MCF MCA
Medical Science MSF MSA
Professional Techniques PTF PTA
Medical Devices MDF MDA

There are also some Soft Skills workshops that are not for credit.

Some topics are covered from different perspectives by different workshop leaders. If you are not sure how to choose between similar workshops, read the workshop abstracts.

Not all workshops are available at all conferences. For further information please refer to the specific conference brochure on the EMWA website.

 
Medical writers with a working knowledge of clinical drug development and some insight into CMC and nonclinical development. Experience writing IBs or IMPDs would be relevant.
 
 
This workshop is aimed at medical writers with some experience of assessing drug safety information, and a basic understanding of the overall drug regulatory environment. It will also be useful to writers who are familiar with previous PSUR requirements detailed in Volume 9A but have little or no experience of the new requirements in line with GVP Module VII and the revised ICH E2C. For writers with no previous experience of pharmacovigilance documents it is recommended that they attend the foundation workshop “Introduction to Pharmacovigilance Writing” before attending this workshop.