Reserve your spot now!
Wednesday, June 4, 2014 @ 3:00 PM IST
Regulatory approval timelines can be reduced significantly by submitting a quality dossier to the Health Agencies. It is important to understand the expectations of the respective Agency while compiling the dossier in order to reduce the number of queries and inturn the approval timeline.
Applicant, Manufacturer, MA Holder, Regulatory Division, Product Development Team, Material Sourcing Personnel, Quality Control Unit, Stability Testing Department, Quality Assurance Peopleand all other stakeholders need to understand these requirements and ensure adherence not only to gain quick approvals but also to remain compliant.
In this webinar we will be covering expected CMC queries w.r.t. each section of the dossier and shall also emphasize on the things to remember while compiling a dossier. The webinar shall be based on EU requirements and will be extrapolated to key regions across the globe.
Topics which will be covered in the webinar :
- Expected CMC queries.
- Things to remember.
- Number of Batches required for filing.
- Best Strategies for proposing commercial scale.
- Stability Requirements for key regions.
- Acceptability of overages.
- Process validation requirements.
- Concept of Leachables and Extractables.
Mr. Manu Babbar
(Presentor, Founder Canton Pharma Consultants)
Mr. Manu Babbar is a post graduate in Pharmaceutics from JamiaHamdard and has a decade of experience with R&Ds of repute in Product Development and Regulatory Affairs. He had been serving Ranbaxy Laboratories Limited as a senior member and carries experience of key global markets such as US, EU, Australia, Russia-CIS etc. He has successfully handled numerous filings including complex variations approved with MHRA. Mr. Babbar has been a speaker in various conferences, seminars and learning sessions related to his field and is also an adjunct faculty with centre for translational and clinical research, JamiaHamdard.
Henow runs his own consultancy (www.cantonpharmaconsultants.com) based at New Delhi which provides dossier writing and regulatory training services to pharmaceutical companies.
Dr. Manoj Karwa
(Host, Head-PPM, Auriga Research Ltd.)
He is Head- Project Planning and Management at Auriga Research Ltd, a CRO based in Delhi. He has done masters in pharmacology from NIPER, Mohali and doctorate in management from IBME, Delhi. He has overall managed more than 150 protocol writing and 70 BA/BE studies for submission to different regulatory authorities. He has managed all phases of clinical trials for drug, medical device, vaccine, cosmetic and herbal products. He has organized three training events in collaboration with Jamia Hamdard, Tata Memorial Hospital and Rajiv Gandhi Cancer Research Institute. These training events were focused on recent clinical trial regulations with special emphasis to preparedness for clinical trial sites. He has more than 10 international articles and posters in recognized journals and conferences respectively. He has also authored free e-learning courses on BA/BE studies, Clinical trials and Indian Regulatory System.
Registration fees for webinar is Rs. 999 INR.
After sucessful registration please make make payment by any of following mode:
- By credit or debit card – http://payit.cc/S1260
- Cheque or DD in favor or ‘Auriga Research Ltd.”, payable at New Delhi.
Kindly send us detail of payment made.
Feel free to contact us for any further query or clarification.
Dr. Manoj Karwa
Contact No. 09540930950