Dr. Muhaned Al-Hindawi
Ex. - Senior Pharmaceutical Assessor
Medicines and Healthcare products Regulatory Agency (MHRA)
- Currently the managing director and principal consultant of “Ontargetpharma Consultancy”, London UK.
- Worked as a Senior Pharmaceutical Assessor with MHRA for more than 10 years.
- During work in MHRA, he made several break-through issues affecting the common understanding by the agency and applicants. Among those are:
- The dissolution performance of multiple- strengths of oral solid dosage forms and how biowaiver can be applied.
- Effect of excipient on the bioavailability of API from aqueous oral solution and biowaiver criteria
- Applicability of GMP standard to manufacture ready-made API mixture
- Technical and quality standards of Vitamin D3 as API and finished product.
- Occupied many technical posts in the pharmaceutical industry with over 20 years of hand on experience in new product development, construction of method of analysis with special interest in HPLC, Stability & kinetics, as well as in technology transfer, and process validation.
- Involved in several high-profile projects:
- In a joint project between Jordan and EU, upgrading the Jordanian pharmaceutical manufacturing companies to comply with the European standards.
- Managed the construction and successful operation of a whole new pharmaceutical manufacturing company (Pharma-International/Amman, Jordan) at a cost of over $40 million.
- Managed the establishment of a new bioequivalence research centre for ACDIMA in Amman, Jordan.
- Prior to joining the pharmaceutical industry, worked in several research and academic institutions whereby many publications have been made.
- Holds a Ph.D. degree from UK, University of Wales, Cardiff, “Effect of Solvent on the Bioavailability of Testosterone Propionate from Oily Injections”.
- Holds an M.Sc. degree by research from UK, Heriot-Watt University, Edinburgh. A thesis was presented about his research on the effect of polymorphism on the solubility of DS and impact on bioavailability.
- A member of the Royal Pharmaceutical Society of GB, pharmaceutical society of NZ and a registered pharmacist in UK.
Dr. Peter Lassoff
Vice President and Head - Global Regulatory Affairs
Peter Lassoff is Vice President and Head of Global Regulatory Affairs at Quintiles. In his role, he works with global clients in the pharmaceutical, medical device, cosmetic, nutrition and other industries on regulatory strategy and implementation to ensure their products are placed on the market in the fastest, least expensive manner. Dr. Lassoff has deep expertise in the development and worldwide registration of medicinal products, biotech products, ‘borderline’ products, medical devices, cosmetics and ‘cosmeceuticals’, nutritional supplements and other regulated healthcare products.
He has registered hundreds of products in Europe, the United States and global markets, including joint NDA/Centralised EMA submissions. He provides regulatory strategies for the development of products for global markets from preclinical to post-marketing as well as expert regulatory due diligence services for companies purchasing products or companies. In addition, Dr. Lassoff has a strong understanding of the value of generics to public health through his long experience with the generics industry. His experience includes working with large pharmaceutical companies to develop strategic go-to-market plans to leverage the demand for branded generics, as well as creating innovative solutions for over-the-counter and hybrid products. Dr. Lassoff has worked in the pharmaceutical industry for 30 years. Prior to joining Quintiles, he held other leadership positions in the CRO field, and has held previous positions at BMS, ConvaTec and Stiefel. Dr. Lassoff holds a Doctor of Pharmacy (PharmD) from the University of Southern California School of Pharmacy.
Dr. Rashmi Hegde
Dr. Hegde is a Paediatrician by training and has vast experience with the Medical departments of both Domestic and International Pharmaceuticals companies. She has been associated for over 2 decades with several global Pharmaceutical companies such as Wockhardt, Piramal, Novartis and Solvay. Dr Hegde has previously led Medical Affairs including Medical Training, Medico-Marketing, Medical Information, Strategic Planning, Clinical Trials, Regulatory, Pharmacovigilance and Medical Scientific Liaison for both Pharmaceutical and Biotechnology companies. Her most recent position prior to the current one has been Director Pharmacovigilance Asia- Africa-Australia-Middle East-India-China for Global Abbott Products GmbH. Dr. Hegde takes a keen interest in Partnering in Medico-Marketing Initiatives, Clinical Trials, Drug Safety Training, Pharmaceutical laws, and Safety Regulations (EU, US FDA & Asia Pacific) and Health Technology.
She was recently awarded the Woman SuperAchiever Award by the 4th World Women Leadership Congress & Awards. She is an external faculty at Narsee Monjee Institute of Management Studies. Dr Hegde has been a prolific speaker and writer at several international scientific forums.
Dr. Ambrish Srivastava
Vice President – Medical Affairs, Clinical Research & Regulatory
After completion of MD in clinical pharmacology worked as Asst Professor in Lady Harding Medical College New Delhi for about 5 years. Worked in various Indian and Multinational pharmaceutical company since last 25 years in various therapy areas including NCE, Generics and biologicals. Participated in several National and International medical conferences as speaker on several diseases and drug therapy. He is a guest faculty in several Institutions and research centres in the area of clinical research and drug development.
Member of Indian Medical Association (IMA), International Society of Pharmacovigilance, and Research Society of Study in Diabetes in India (RSSDI). He has about 40 publications in Indian and International medical journals. He has been awarded Vishisht Chikitsa Medal in 1994 by Governor of Andhra Pradesh and Rashtriya Ratan Award in 2005 by Governor of Gujarat for community health.
Head Regulatory & Project Management
RPG Life Sciences Ltd
Regulatory Affairs, Sanofi India Limited
Head Regulatory Affairs ROW
Dr. Manish Verma
Director Medical Affairs
Sanofi India Ltd
Director & Head Center of Excellence for Global Regulatory Platform and Delivery
GlaxoSmithKline Pharmaceuticals Limited
Narendra has over 16+ years pharmaceutical industry experience in various domains such as Regulatory Affairs (Regulatory Strategy, Regulatory Operations), Analytical Development, QA/QC, Service Industry. Presently he is associated with Novartis since December 2010 and working as Senior Global Maintenance Regulatory Manager in RA Established Medicines Franchise. He is currently pursuing an MS in Regulatory Affairs and Health Policies (Massachusetts college of Pharmacy and Health Sciences, USA). He likes to travel and explore new places.
Head of Regulatory Affairs – ROW & USA
Concordia International (Formerly AMCo)
Chikkam Rama Mohan Rao
Senior Director - Global RA Operations
Chikkam Rama Mohan Rao comes up with very rich experience of above 20 years and out of which 18 years of Global Regulatory Operations experience in various regulatory life science tools. As a part of Global Regulatory operations, handling Regulatory Submissions (Electronic & Paper Publishing), Labelling and Regulatory Information Management System. Chikkam at present working in Novo Nordisk Service Centre India Private Limited, Bangalore as Senior Director – Global Regulatory Operations and play a higher management role both in Bangalore and Denmark.
Head Regulatory Affairs and Project Management
RPG Life Sciences
Suchitra has a varied experience of around 26 years in Pharma Industry out of which 16 years in Regulatory Affairs function with Global Regulatory filings.
Her gamut of experience spans from hands on Regulatory experience for API & Formulations filings into Regulated & Semi-regulated markets such as USA, EU, and ANZ to ASEAN, African & LATAM countries resulting into many ANDAs, MAs, DMFs, CEPs to the credit. In a career span of more than 26 years, worked in different companies’ major ones are J.B. Chemicals & Pharmaceuticals Ltd., Nicholas (I) Ltd., JK Pharmaceuticals. etc. at different capacities in different functions such as R&D, QA, QC and in Regulatory affairs. Last 16 years exclusively been working in Regulatory Affairs function out of which last 7years in heading the dept. At RPG Life Sciences Ltd works as Head – Regulatory & Project Management and responsible for various technical/ regulatory decisions and strategies.
Experience also covers as handling inspections with Regulatory authorities such as MHRA, USFDA, MCC, TGA, and various overseas eminent pharma companies. Travelled abroad on various official responsibilities. Suchitra has completed B. Pharm from UDCT (now known as ICT- Mumbai) in 1985 & an alumni of IIM- Calcutta for completing Executive program in Senior Management.
Director & Head - India, Global Regulatory Platforms and Delivery (GRPD), Research & Development
GlaxoSmithKline Pharmaceuticals Limited
Group Leader - Regulatory Affairs
Vice President and Head of Global Regulatory
Dr. Ambrish Srivastava
Vice President - Medical Affairs, Clinical Research and Regulatory
Dr. Manish Verma
Director Medical Affairs
Dr Manish Verma is an Internal Medicine specialist, a clinical practitioner turned pharmaceutical physician with over 15 years of experience in clinical research, new drug development and patient support programs in the field of non-communicable diseases mainly, diabetes, cardiovascular diseases and consumer healthcare. His recent area of work and focus has been digital healthcare. Currently he is working as Head of Medical Affairs, CHC, South Asia Zone, Sanofi. Has published several papers in journal of high repute and presented at various national and international conferences. Has moderated several multi-stakeholder meetings and also served as scientific committee member for the countries first ever white paper for strengthening policies on diabetes care.