EXTEDO´s Overview on current and future Regulatory/IT Requirements for Life Sciences Companies

We kindly invite you to its upcoming RIMS workshop in Midrand, South Africa on 17th October 2016.

During the day-long workshop, our team of experts will cover a wide range of topics, including the state of eCTD submissions management in South Africa, the worldwide submissions requirements and their impact on pharmaceutical companies and more. We will also demonstrate EXTEDO´s latest software solutions and present real-life case scenarios. 

The event is free of charge and is designed to discuss the challenges that life sciences companies are facing. 

Register now!

Agenda

Time

Topic

08.30 - 09.00

Registration

09.00 - 09.30

EXTEDO company and solution overview 

09.30 - 10.00

Past and current CTD / eCTD situation for South Africa 

10.00 - 10.30

Case Study 1: Working with eCTD from a regulatory consultant perspective

10.30 - 11.00

Coffee break

11.00 - 12.00

Submission management and publishing with eCTDmanager

12.00 - 12.30

eSUBmanager 

The newest EXTEDO solution for submission & (WEB)viewing

12.30 - 14.00

Lunch break

14.00 - 14.30.

Case Study 2: Working with eCTD from an industry perspective

15.00 - 15.30

PcVmanager

Your drug safety database solution

15.30 - 16.00

Break

16.00 - 16.30

Validation with EURSvalidator

16.30 - 17.00

Overview on worldwide regulations & their impact on the pharmaceutical industry

Speakers

Schei Dattner

Schei Dattner has more than 25 years of experience in the Life Sciences Industry. In 2003 he founded sales4u, a sales and marketing outsourcing company based in Germany. Since 2004, he is a certified partner of EXTEDO and supports EXTEDOs sales team with his extensive knowledge in submission management, pharmacovigilance management, IDMP and document management. 

Anita Smal

Anita Smal is a pharmacist with extensive experience in regulatory, quality and scientific affairs in the pharmaceutical industry. She joined Abex Pharmaceutica (Pty) Ltd in 2007. Abex Pharmaceutica became the professional partner of EXTEDO in South Africa in 2009. Through this partnership, Anita contributed to the development of the specification and guidelines for the implementation of the eCTD standard in South Africa. 

Laura Magnus

Laura Magnus qualified at Rhodes University with a degree in pharmacy, which she achieved with distinction and academic honours. After achieving her Masters degree in Pharmaceutics she started her career at Actavis Pharma and became regulatory manager in 2014. Due to the Actavis-Teva merger in August this year, she has just recently moved sectors from regulatory South Africa for Actavis to heading up regulatory Africa for Teva. Laura has also lately widened her area of expertise and now plays an important part in business development and product portfolio for Teva.  

Venue

Accolades Boutique Venue

72 Dale Road Midrand, 1685

South Africa

Tel: +27 (0)87 0220370

http://accolades.org.za/

 

Please book your hotel room yourself. Just let us know in case you need support. We look forward to meeting you at the event.

Registration (free of charge):

 

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