The quality and clarity of written technical documents is vital to the success of pharmaceutical companies. Such documents are used in regulatory submissions, to report the outcome of development work to clients, to record the results of investigations and to guide the direction of internal projects. In this course, participants will learn how to analyze and present technical data in a clear and concise manner. The use of visual tools such as graphs and flow charts will be covered, together with the design of effective tables. Statistical tools for data reduction and analysis will also be covered. The elements of effective standard operating procedures will also be explained. A large part of the course will be spent in a workshop setting, where attendees will produce technical content for comment and evaluation. The workshop can either be based on participants’ own data or model data provided by the trainer.
Attendees will be expected to bring a laptop computer. By the end of the course, attendees will be able to:
- Understand the expectations of regulators when reviewing a NDA/BLA/MAA
- Edit documents to remove superfluous words or phrases
- Identify and correct ambiguous text
- Write effective technical reports and procedures that cater to the needs of their target audience
- Present complex experimental data in a logical, clear and concise manner making optimal use of graphs, charts and tables
- Follow the conventions of scientific writing to support explanations and arguments
- Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common mistakes in written English
- Analyze experimental data using statistical principles
Learning Objectives:
- Information required in regulatory submissions
- eCTD format and style
- The fundamentals of effective writing: accuracy, brevity and clarity
- Common mistakes in written English
- Effective use of figures and tables
- Correct methods of citing literature sources in technical documents
- Types of data distribution
- Statistical treatment of experimental data
- Design of Experiments (DoE)
- Writing effective procedures
Who will Benefit:
- Regulatory affairs professionals
- Project managers
- Technical staff with responsibility for report/procedure writing
- Quality management
- 08:30 AM – 08:59 AM – Registration Process, Meet & Greet
- 9:00 AM - 10:30 AM
- Regulatory expectations
- ICH, US FDA and EMA guidance on eCTD submissions
- How much information to include
- 10:30 AM - 10:45 AM Break
- 10:45 AM - 12:00 Noon
- Writing appropriately for the audience – who will read your report?
- Organization and structure of technical reports
- Use of templates
- Conventions and style in scientific writing
- Correct use of English
- Length and structure of sentences
- Citing scientific literature
- Exercise: identifying and correcting poor writing
- 12:00 Noon - 1:00 PM Lunch
- 1:00 PM - 3:00 PM
- Statistical methods
- Types of data distribution
- Basic statistical terms and techniques
- Tests for normality
- Outliers
- Analysis of variance
- Introduction to experimental design
- Exercise: using appropriate statistical techniques
- 3:00 PM - 3:15 PM Break
- 3:15 PM - 4:30 PM
- Graphical presentation of data
- Options for presenting data in technical documents
- Designing effective figures and tables
- Use of error bars
- Graphics tools in Microsoft Excel®
- Exercise: selecting appropriate data presentation methods
- 8:30 AM - 8:59 AM Attendees arrive
- 9:00 AM - 10:30 AM
- Writing effective procedures
- Differences in style between technical reports and procedures
- SOP structure
- Developing an effective procedure – risk-based approach
- Use of diagrams and pictures
- Procedure lifecycle management
- Regulatory observations
- Exercise: reviewing a SOP
- 10:30 AM - 10:45 AM Break
- 10:45 AM - 12:00 Noon
- Workshop/group exercise: review of example reports – identifying good and bad practice
- 1:00 PM - 3:00 PM Report-writing workshop
- 3:00 PM - 3:15 PM Break
- 3:15 PM - 4:15 PM Report-writing workshop (continued)
- 4:15 PM - 4:30 PM Final questions, feedback and close
Mark Powell
Director, Mark Powell Scientific Limited
Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for method development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programs as well as establishing collaborations with academia and instrument manufacturers. His work resulted in a number of published papers and presentations at international scientific conferences. In 2013, he set up his own company to provide training and consultancy services to pharmaceutical professionals. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programs and conducting data integrity audits. He is in demand as a trainer in topics such as chromatography, spectroscopy, pharmaceutical dissolution testing, data integrity, control of impurities, stability/stress studies and sample preparation, as well as technical writing.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656
Media Partner:
Local Attractions of Boston, MA
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
North End
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.
