Gateway to the European and U.S. Pharmaceutical Market (Overall aspects of Pharma Registrations)

Gateway to the European and U.S. Pharmaceutical Market (Overall aspects of Pharma Registrations)

 

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    INR 6000
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    INR 6500
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About The Event

!! SPONSORSHIP WELCOME!!

We are proud to announce our public seminar in Mumbai concerning EU & US Regulations, Requirements & Registrations

In order to clarify the different EU & US registrations on Pharmaceutical Products, Pharmaceutical Ingredients & APIs.  Swami Samarth Pharmatech, Mumbai, India  Organises  One day Seminar on 

“Gateway to the European and U.S. Pharmaceutical Market”

 06th October 2011 at The Mirador 131 / B, New Link Road, Chakala, Andheri (East), Mumbai, Maharashtra, Pin: 400 099, India, Phone : +91-22-4248 5000      

This Seminar will be lead by Ms. Cornelia Camara, MSc, Expert Partner and Managing Director of Camara and Partners & Ms. Béatrice Janin Jacquat, MD, Expert Partner, Camara and Partners, Switzerland

Ms. Cornelia is a biochemist with more than 16 years of industries experience. She held several positions in major pharmaceutical and biotech companies such as Merck Serono, Sanofi Aventis and Debiopharm. Her main expertise relies in regulatory affairs, chemistry, manufacturing and controls.

Ms. Beatrice has more than 17 years experience in non clinical and clinical research, providing medical and statistical direction and support for companies in various medical fields. She acquired international/global experience while working as a medical, scientific expert and statistician for numerous biotech, start up  and pharma companies. Her main expertise relies in clinical development and biostatistics.

The Seminar is targeted to Pharmaceutical Industries and API Manufacturers.

R&D managers and personnel, QA/QC managers and personnel, regulatory managers and personnel, clinical managers and personnel, investors and anyone involved in pharmaceutical development.  CEOs, Quality Directors and Pharma Staff of Indian  Pharmaceutical Products & API manufacturers. It will give the participants a sound overview of the relevant requirements for Registrations in Europe and the fields of applications of the different regulations.

The topics will be:

  1. European and US regulatory, including case studies
  2. CMC regulatory requirements, including case studies
  3. EU & US agency meetings  
  4. Clinical trials in India and validity for European and US registration Mandatory   pediatric investigational plan EU/US
  5. Interactive case study “from concept to submission  ”Covering all aspects – regulatory, CMC, preclinical, clinical, submission
  6. Introduction to eCTD submission (EU, US, Japan, WHO)

We look forward to have you as a participant in this event. Thank you for taking notice of our advertisement.

Details and Registration Form Attached

Seminar Faculty and Speakers:

 1. Cornelia Camara, MSc, Expert Partner and Managing Director of Camara and   Partners,  Switzerland

   2. Béatrice Janin Jacquat, MD, Expert Partner, Camara and Partners, Switzerland

Registration Fee:  

6500 P.P + 10.3% Service Tax,

Lunch and coffee breaks included.

Reduced fee until 10th August 2011:

6000 P.P + 10.3% Service Tax

Registration Deadline: 20th September 2011

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