March Event: The European Regulatory Landscape: What You Need to Know


Monthly Program:

Wednesday, March 28, 2018

The European Regulatory Landscape: What You Need to Know


Program Speaker:

Stephen Thompson, PhD Director of Regulatory Affairs S-cubed Ltd Oxford, UK

Event Agenda: Date:

Wednesday, March 28, 2018

Time: 5:15 – 6:00 PM Registration & Snacks

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A


BD (directions on last page of this flyer)

6055 Lusk Blvd

San Diego, CA 92121

Program Topic:

While the basic premise for approval of marketing applications for medicinal products in the European Union (EU) is quality, safety and efficacy, there are a number of EU specific regulatory considerations that need to be factored into the overall drug development process. For example, the timing and nature of interactions with the European Medicines Agency and other National Regulatory Agencies are different from those of the FDA. There are also specific differences in the procedures and requirements for orphan designation and pediatric development, as well as considerations for the logistics of importation and testing.

Program Summary:

This presentation will highlight a number of these EU regulatory considerations that may not be immediately apparent to sponsors based in the USA. It will aim to present a high-level understanding of regulatory considerations in European Union, what to expect when developing products for the EU, and EU-specific timelines and procedures.

Specifically, you will learn:

  • Who the Regulatory Agencies are and what they regulate

  • Who to ask for Scientific Advice and why

  • Pediatric development: The need for Pediatric Investigation Plans, their timing and impact

  • Orphan Drugs: designation requirements and incentives

  • How the EU addresses the unique needs of micro, small and medium-sized enterprises (SMEs) with administrative, regulatory and financial support

  • Logistical considerations for drug supply, import and testing

Speaker Biography:

Dr. Thomson has over 18 years’ regulatory affairs experience in the pharmaceutical industry working for regulatory consultancies and large CROs, before moving to S-cubed Ltd as Director of Regulatory Affairs in March 2009. Stephen has provided a wide range of regulatory advice and submission support to pharma and biotech companies in Europe and the USA and has worked with many European national regulatory agencies, EMA and the US FDA. Stephen has a proven track-record of successfully supporting products through development to registration and subsequent license maintenance. Stephen holds a PhD in Chemistry.

Please make your reservation early. The online registration due date is Monday March 26, 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door.

Online Pre-registration (through Monday March 26, 2018): $15 SDRAN Member, $25 Non-Member

Onsite Registration: $25 SDRAN Member, $35 Non-Member

For Questions Email:



From the North 5:

I-5 South toward San Diego

Keep left and continue on I-805 South

Take exit 27 toward Mira Mesa Blvd

Take Mira Mesa Blvd to Lusk Blvd

Turn left on to Sorrento Valley Road

Stay on the road until it turns into Mira Mesa Blvd

Move to the left-hand lane

At the light - On the left (notice Holiday Inn Express & Chili's)

Turn left on to Lusk BlvdTurn at the first right hand

Turn at the first left hand (opposite Chili’s)

BD, Bldg. “C” is straight ahead

From the South 5:

I-5 North

From the right hand lane, take Exit 27A for Mira Mesa Blvd

From the right hand lanes, turn right on to Mira Mesa Blvd

Move to the left-hand lane

At the light - On the left you will notice:Holiday Inn Express / Chili's

Turn left on to Lusk Blvd

Turn at the first right hand

Turn at the first left hand (opposite Chili’s)

BD, Bldg. “C” is straight ahead